Placement manipulator and attachment for positioning a puncture instrument
Summary by NHIP
Rotary needle placement apparatus
The apparatus holds a needle-like instrument and rotates it around a remote center of motion to trace a conical region of coverage. An attachment changes the base body's inclination relative to the subject, shifting the conical region by an angle proportional to that change so the needle axis intersects targets outside the original coverage area.
Claim Score by NHIP
Abstract
An apparatus (51) includes a needle placement manipulator (1) and an attachment (52) for the manipulator. The manipulator includes a needle holder and a rotary mechanism. The rotary mechanism (3, 4) has a remote center of motion (RCM: 11) and is configured to position a needle holder (5) such that the axis of the needle holder traces a conical region of coverage (108), the conical region of coverage having the apex thereof at the RCM and the base thereof in a direction towards a subject of needle placement (14). The attachment supports the guide mechanism and is configured to be mounted onto the subject of needle placement. The attachment includes a guide portion (183c) configured to change an inclination of the rotary mechanism with respect to the subject of needle placement such that the axis of the needle holder intersects an insertion target (14) located outside of the conical region of coverage.

Term
Projected expiry 23 October 2038.
- Priority
- Filed
- Granted
- Today
- Projected expiry
35 claims: 2 independent, 33 dependent
- 1Broadest claimClaim Score 54, average(NHIP)An apparatus, comprising:a needle holder having an axis and configured to hold a needle-like instrument aligned relative to a subject of needle placement;a rotary mechanism having a remote center of motion and configured to rotate the needle holder such that the axis of the needle holder passes through the remote center of motion and traces a first conical region of coverage on the subject of needle placement;a base body rigidly fixed to the rotary mechanism;and an attachment that supports the base body and is configured to be mounted onto the subject of needle placement, wherein the attachment changes an inclination of the base body with respect to the subject of needle placement and shifts the first conical region of coverage by an angle proportional to the change in inclination such that the axis of the needle holder intersects an insertion target located outside of the first conical region of coverage.
- 30An attachment for use with a radio frequency (RF) coil when an image of a subject of needle placement is captured by a magnetic resonance imaging (MRI) modality, the attachment comprising:a protruding portion configured to be fitted into an opening of the RF coil;and a guide portion having an inclined surface configured to support a needle placement manipulator in an inclined manner above the RF coil;the needle placement manipulator comprising a rotary mechanism having a remote center of motion and configured to rotate a needle holder such that an axis of the needle holder passes through the remote center of motion and traces a first conical region of coverage on the subject of needle placement, wherein the guide portion is wedge-shaped and configured to change an inclination of the needle placement manipulator with respect to the subject of needle placement and to shift the first conical region of coverage by an angle proportional to the change in inclination such that the axis of the needle holder intersects an insertion target located outside of the first conical region of coverage.
Independent claims2
226 paragraphs in 6 sections, as filed
CROSS-REFERENCE TO RELATED APPLICATIONS
0001The present application claims priority from U.S. provisional patent application No. 62/410,123 filed Oct. 19, 2016, the disclosure of which is hereby incorporated by reference herein in its entirety.
BACKGROUND OF THE INVENTION
Field of the Invention
0002The present disclosure generally relates to medical devices, and in particular it relates to a placement manipulator for holding and positioning a puncture instrument in minimally invasive puncture therapy and to an attachment for adjusting and holding the posture of the needle placement manipulator.
Description of Related Art
0003Medical devices for in-vivo diagnostic testing, therapy treatment and surgery of patients are well known. Typical procedures for minimally invasive therapy include a percutaneous puncture therapy in which various instruments such as needles and/or catheters are carefully guided into an affected area of a patient. Examples of puncture therapy include ablation, which is a treatment performed by burning tumor or cancer cells with radiation waves, and cryotherapy in which tumor and cancerous cells are frozen with a refrigerant, cooling gas, or the like. In addition, puncture biopsy is widely performed as part of pathological diagnosis based on tissue collection. Another example is percutaneous microwave coagulation (MC) therapy, which is a minimally invasive surgery, used in malignant liver tumor treatments. In the MC technique, to destroy an entire malignant liver tumor, tumor size and accessibility of the lesion are factors to be considered. For example, for a small liver tumor, microwave coagulation (MC) can be performed with only a single needle, whereas to cover irregular and large tumors, a series of single-needles is required to apply multiple overlapping MC treatment. The multiple-needle surgical planning requires a needle collision-free reachable workspace, which is a set of needle insertion trajectories that reach the target with no collision between the needle and obstacles. See, for example, Liu, et al., “Automatic Multiple-Needle Surgical Planning of Robotic-Assisted Microwave Coagulation in Large Liver Tumor Therapy”, PLoS ONE 11(3): e0149482, Mar. 16, 2016.
0004To accurately position the needle to a target, such as a tumor, in such puncture therapy, medical images acquired using a medical imaging modality, such as an X-ray computed tomography (CT) scanner or a magnetic resonance imaging (MRI) scanner, are used to visualize the position and trajectory of the needle in the body. In such puncture therapy using such visualization modality, it is difficult to reach target tissue by one puncture, and medical image acquisition is performed a plurality of times to perform planning based on the acquired images to reach the target tissue while correcting the puncture path little by little in a stepwise manner. For that reason, to reduce the surgery time and burden on the patient, development of a needle placement manipulator for positioning the needle to a target tissue with few path correction times has been proposed. In particular, a body-mount needle placement manipulator that is to be directly mounted on the body surface of a patient has been proposed.
0005U.S. Patent Application Publication No. 2014/0275978 discloses an example of the body-mount needle placement manipulator which includes a pair of rotary guides mounted at a fixed angle with respect to each other for determining the direction of the needle on the basis of a remote center of motion (RCM) of the rotary guides.
0006U.S. Patent Application Publication No. 2014/0275978 discloses a method for disposing, on a patient's body, a needle placement manipulator and a radio-frequency (RF) coil without interference with each other. The method employs a single-loop RF coil, which is one kind of surface coil, as the RF coil and uses a first attachment including a base surface in contact with the patients' body and a disposition portion on which the RF coil is disposed and a second attachment connected to a base body of the manipulator. In this manner, the manipulator and the single-loop RF coil can be disposed without interference with each other. However, the range of coverage for reaching a needle insertion target on the patient tends to be limited.
0007To increase the positioning range (range of coverage) using the needle placement manipulator with the method disclosed in U.S. Patent Application Publication No. 2014/0275978, it is necessary to increase the mount angle of the second rotation guide with respect to the first rotation guide. To increase the mount angle of the second rotation guide with respect to the first rotation guide, it is necessary to reduce the external dimensions of the second rotation guide or to dispose the second rotation guide farther away from the first rotation guide in order to prevent interference between the rotation guides. When the external dimensions of the second rotation guide are reduced, the opening of the second rotation guide in which a needle holder is disposed is reduced in size. This can make it difficult for the needle to access a skin in the vicinity of the puncture point through the opening and can cause interference between the needle holder and the second rotation guide. When the second rotation guide is disposed farther away from the first rotation guide, the height of the needle placement manipulator increases as the mount angle of the second rotation guide with respect to the first rotation guide increases, which increases the size of the manipulator, and therefore can cause interference between the needle placement manipulator and the bore of the MRI or X-ray CT scanner.
0008For the above reasons, it is not easy to increase the coverage of the body-mount needle placement manipulator disclosed in U.S. Patent Application Publication No. 2014/0275978. In addition, in U.S. Patent Application Publication No. 2014/0275978, if the target tissue is not within the coverage of the needle placement manipulator after the second attachment is disposed on the patient's body, a repetition of an attachment operation, such as repositioning the first attachment and the RF coil on the patient's body from the beginning, and again mounting the needle manipulator becomes necessary. The reoperation can increase a burden on the patient due to an extended operation time and can increase safety risks because, for example, the sterilized needle placement manipulator may come into contact with non-sterilized objects, such as the RF coil.
SUMMARY OF THE INVENTION
0009In view of the above, the present disclosure provides a needle placement manipulator having an increased coverage and an attachment of the needle placement manipulator capable of adjusting the coverage of the needle placement manipulator even if a needle insertion target (tissue target) results to be out of coverage of the needle placement manipulator after the needle placement manipulator is placed on the patient's body.
0010According to one embodiment, the present disclosure provides an attachment including a needle holder, a guide mechanism, an engaging unit, and a mount surface, as well as a needle placement manipulator. The guide mechanism is configured to hold a needle along an insertion axis. The guide mechanism is configured to position the insertion axis in a predetermined direction relative to a target tissue. The engaging unit is configured to support and fix an apparatus main body that supports the guide mechanism. The mount surface is configured to be placed on a subject of needle placement. The attachment includes an inclined surface configured to change the apparatus main body to a predetermined posture with respect to the mount surface and an adjusting unit configured to change an inclination angle or a bearing of the inclined surface. The apparatus main body and the attachment each include a restraining unit configured to restrain a relative position of each other. The needle placement manipulator is configured such that the apparatus main body is fixed to the attachment with the engaging unit.
0011According to another embodiment, the present disclosure provides an apparatus, comprising: a needle holder (<b>5</b>) having an axis (<b>5</b><i>a</i>) and configured to hold a needle (<b>12</b>) aligned relative to a subject of needle placement (<b>15</b>); a rotary mechanism (<b>3</b>, <b>4</b>) having a remote center of motion (RCM: <b>11</b>), the rotary mechanism (<b>3</b>, <b>4</b>) configured to position the needle holder (<b>5</b>) such that the axis of the needle holder traces a conical region of coverage, the conical region of coverage having the apex thereof at the RCM and the base thereof in a direction towards the subject of needle placement (<b>14</b>); a base body (<b>2</b>) configured to be rigidly fixed to the guide mechanism (<b>3</b>, <b>4</b>); and an attachment (<b>52</b>, <b>183</b>)) that supports the base body and configured to be mounted onto the subject of needle placement. The attachment (<b>183</b>) comprises: a fitting portion (<b>183</b><i>a</i>) configured to engage with the base body, and a guide portion (<b>183</b><i>c</i>) configured to change an inclination of the rotary mechanism with respect to the subject of needle placement, wherein the guide portion changes the inclination of the rotary mechanism such that the axis of the needle holder intersects an insertion target located outside of the conical region of coverage.
0012According to the various embodiments of the present disclosure, even if it is found that the target tissue is outside of the coverage of a needle placement manipulator after the needle placement manipulator is placed on a patient's body, the coverage can be corrected by adjustment using the attachment so that the target issue falls within the coverage.
0013Further features of the present invention will become apparent from the following description of exemplary embodiments with reference to the attached drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
<figref idref="DRAWINGS">FIGS. 1A, 1B, and 1C</figref> are schematic perspective views of an apparatus main body according to a first embodiment of the present disclosure.
<figref idref="DRAWINGS">FIG. 2A</figref> is a schematic cross-sectional view of the apparatus main body.
<figref idref="DRAWINGS">FIG. 2B</figref> is an enlarged view of a dashed-line region A in <figref idref="DRAWINGS">FIG. 2A</figref>.
<figref idref="DRAWINGS">FIG. 3</figref> is a schematic perspective view of a needle placement manipulator according to the first embodiment.
<figref idref="DRAWINGS">FIG. 4A</figref> is a schematic perspective view of an attachment according to the first embodiment.
<figref idref="DRAWINGS">FIG. 4B</figref> is a schematic perspective view of a cross section of the attachment.
<figref idref="DRAWINGS">FIGS. 5A and 5B</figref> are schematic cross-sectional views of the needle placement manipulator illustrating puncture using the needle placement manipulator.
<figref idref="DRAWINGS">FIG. 6</figref> is a schematic perspective view of a needle placement manipulator according to the first embodiment.
<figref idref="DRAWINGS">FIG. 7A</figref> is a schematic perspective view of an attachment according to the first embodiment.
<figref idref="DRAWINGS">FIG. 7B</figref> is a schematic perspective view of a cross section of the attachment.
<figref idref="DRAWINGS">FIG. 8A</figref> is a cross-sectional view of the needle placement manipulator.
<figref idref="DRAWINGS">FIG. 8B</figref> is an enlarged view of a dashed-line region B in <figref idref="DRAWINGS">FIG. 8A</figref>.
<figref idref="DRAWINGS">FIGS. 9A and 9B</figref> are schematic cross-sectional views of the needle placement manipulator illustrating simulated puncture.
<figref idref="DRAWINGS">FIGS. 10A, 10B, and 10C</figref> are diagrams illustrating the coverage of the needle placement manipulator.
<figref idref="DRAWINGS">FIG. 11A</figref> is a schematic perspective view of a needle placement manipulator according to the first embodiment.
<figref idref="DRAWINGS">FIG. 11B</figref> is an enlarged view of a dashed-line region C in <figref idref="DRAWINGS">FIG. 11A</figref>.
<figref idref="DRAWINGS">FIG. 12</figref> is a schematic perspective view of a needle placement manipulator according to a second embodiment of the present disclosure.
<figref idref="DRAWINGS">FIG. 13</figref> is a schematic perspective view of an attachment according to the second embodiment.
<figref idref="DRAWINGS">FIG. 14A</figref> is a schematic cross-sectional view of the attachment <b>122</b>.
<figref idref="DRAWINGS">FIG. 14B</figref> is an enlarged view of a dashed-line region D in <figref idref="DRAWINGS">FIG. 14A</figref>.
<figref idref="DRAWINGS">FIGS. 15A and 15B</figref> are schematic cross-sectional views of the needle placement manipulator illustrating simulated puncture.
<figref idref="DRAWINGS">FIG. 16A</figref> is a schematic perspective view of a first attachment according to a third embodiment of the present disclosure.
<figref idref="DRAWINGS">FIG. 16B</figref> is a schematic perspective view of a second attachment according to the third embodiment.
<figref idref="DRAWINGS">FIG. 16C</figref> is a schematic perspective view of a single loop coil.
<figref idref="DRAWINGS">FIG. 17A</figref> is a schematic perspective view of a first needle placement manipulator of the third embodiment.
<figref idref="DRAWINGS">FIG. 17B</figref> is a schematic perspective view of a second needle placement manipulator of the third embodiment.
<figref idref="DRAWINGS">FIG. 18A</figref> is a schematic cross-sectional view of the first needle placement manipulator illustrating simulated puncture.
<figref idref="DRAWINGS">FIG. 18B</figref> is a schematic cross-sectional view of the second needle placement manipulator illustrating simulated puncture.
<figref idref="DRAWINGS">FIG. 19</figref> is a schematic perspective view of a phased array coil according to a fourth embodiment of the present disclosure.
<figref idref="DRAWINGS">FIG. 20</figref> is a schematic perspective view of a phased array coil disposed on the phased array coil.
<figref idref="DRAWINGS">FIGS. 21A, 21B, and 21C</figref> are schematic perspective views of an attachment according to the fourth embodiment.
<figref idref="DRAWINGS">FIGS. 22A and 22B</figref> are schematic cross-sectional views of the attachment.
<figref idref="DRAWINGS">FIGS. 23A and 23B</figref> are schematic cross-sectional views of the needle placement manipulator illustrating simulated puncture.
<figref idref="DRAWINGS">FIG. 24</figref> is a diagram illustrating the coverage of the needle placement manipulator.
<figref idref="DRAWINGS">FIG. 25</figref> is a schematic perspective view of a needle placement manipulator according to a fifth embodiment of the present disclosure.
<figref idref="DRAWINGS">FIGS. 26A and 26B</figref> are schematic perspective views of an attachment of the fifth embodiment.
<figref idref="DRAWINGS">FIGS. 27A and 27B</figref> s are schematic cross-sectional views of the needle placement manipulator illustrating simulated puncture.
<figref idref="DRAWINGS">FIG. 28A</figref> is a schematic perspective view of the attachment.
<figref idref="DRAWINGS">FIG. 28B</figref> is a schematic plan view of the attachment.
<figref idref="DRAWINGS">FIGS. 29A and 29B</figref> are diagrams illustrating the coverage of the needle placement manipulator.
<figref idref="DRAWINGS">FIG. 30</figref> is a diagram illustrating the coverage of the needle placement manipulator.
<figref idref="DRAWINGS">FIG. 31A</figref> is a schematic perspective view of a needle placement manipulator disposed on a phased array coil according to a sixth embodiment of the present disclosure.
<figref idref="DRAWINGS">FIG. 31B</figref> is a schematic perspective view of the needle placement manipulator disposed on the phased array coil according to the sixth embodiment.
<figref idref="DRAWINGS">FIGS. 32A and 32B</figref> are schematic perspective views of the attachment.
<figref idref="DRAWINGS">FIG. 32C</figref> is an enlarged view of a dashed-line regions E in <figref idref="DRAWINGS">FIG. 32A</figref>.
<figref idref="DRAWINGS">FIG. 32D</figref> is an enlarged view of a dashed-line regions F in <figref idref="DRAWINGS">FIG. 32A</figref>.
<figref idref="DRAWINGS">FIGS. 33A and 33B</figref> are schematic perspective views of a movable portion of the sixth embodiment.
<figref idref="DRAWINGS">FIGS. 34A, 34B, 34C, and 34D</figref> are schematic cross-sectional views of the needle placement manipulator illustrating simulated puncture.
<figref idref="DRAWINGS">FIG. 35A</figref> is a schematic perspective view of a needle placement manipulator according to a seventh embodiment disposed on the phased array coil.
<figref idref="DRAWINGS">FIG. 35B</figref> is a schematic perspective view of the needle placement manipulator disposed on the phased array coil.
<figref idref="DRAWINGS">FIGS. 36A, 36B, and 36C</figref> are schematic perspective views of the attachment, according to a seventh embodiment.
<figref idref="DRAWINGS">FIGS. 37A and 37B</figref> are schematic perspective views of a movable portion of the seventh embodiment.
<figref idref="DRAWINGS">FIG. 38</figref> is a schematic perspective view of a fixed portion of the seventh embodiment.
<figref idref="DRAWINGS">FIGS. 39A and 39B</figref> are schematic cross-sectional views of the needle placement manipulator illustrating simulated puncture.
<figref idref="DRAWINGS">FIGS. 40A and 40B</figref> are schematic plan views of the needle placement manipulator illustrating simulated puncture.
<figref idref="DRAWINGS">FIGS. 41A, 41B and 41C</figref> respectively illustrate perspective, top, and bottom views of a first example an attachment designed as a statically inclined adapter according to a seventh embodiment.
<figref idref="DRAWINGS">FIGS. 42A, 42B and 42C</figref> respectively illustrate perspective, top, and bottom views, and <figref idref="DRAWINGS">FIGS. 42D and 42E</figref> illustrate side views of a second example of an attachment designed as a statically inclined adapter according to the seventh embodiment.
<figref idref="DRAWINGS">FIG. 43</figref> illustrates exemplary functionality and application of the statically inclined adapter during a percutaneous puncture operation according to the seventh embodiment.
<figref idref="DRAWINGS">FIGS. 44A and 44B</figref> illustrate further exemplary functionality and applications of the attachment designed as a statically inclined adapter during a percutaneous puncture operations according to the seventh embodiment. <figref idref="DRAWINGS">FIG. 44C</figref> illustrates an example an attachment designed as a statically inclined adapter for a needle placement manipulator where the attachment includes multiple wedge-shaped adapters stacked onto each other.
<figref idref="DRAWINGS">FIG. 45</figref> illustrates an example of using a curved base to mount one ore more attachments having an inclined surface onto a subject's body such that a needle placement manipulator will avoid interference with parts of a phased array RF-coil.
<figref idref="DRAWINGS">FIGS. 46A and 46B</figref> show side view arrangements of a base having a curved mounting surface configured to fit the contour shape of a patient's body.
<figref idref="DRAWINGS">FIGS. 47A, 47B, and 47C</figref> show perspective and cross-sectional views of an embodiment of an attachment mounted onto one or more linear guides which are configured as fixed distance translational adapters.
DESCRIPTION OF THE EMBODIMENTS
0076The present disclosure will be described hereinbelow with reference to the attached drawings. It is to be understood that the present disclosure is not limited to the various embodiments described. Needle placement manipulators and attachments therefor resulting from any combination of the various embodiments are also within the scope of the present disclosure.
First Embodiment
0077Referring to <figref idref="DRAWINGS">FIGS. 1A and 1C</figref> to <figref idref="DRAWINGS">FIGS. 11A and 11B</figref>, a first embodiment of the present disclosure will be described. <figref idref="DRAWINGS">FIGS. 1A to 1C</figref> are schematic perspective views of an apparatus main body <b>1</b>, which is part of a needle placement manipulator viewed from different angles, according to the first embodiment. The apparatus main body <b>1</b> is a remote center of motion (RCM) mechanism having two degrees of freedom in rotation. In the present embodiment, an X-ray computed tomography (CT) scanner is used to visualize the inside of a patient's body, medical devices, medical-device guide devices, etc. First, the structure of the apparatus main body <b>1</b> will be described. A first rotation guide <b>3</b> that is rotatable about an axis <b>8</b> is mounted on a base body <b>2</b> of the apparatus main body <b>1</b>. A rigid cover <b>10</b> is mounted on the first rotation guide <b>3</b>. A second rotation guide <b>4</b> is mounted onto the rigid cover <b>10</b>. A needle holder <b>5</b>, for guiding a needle <b>12</b> along an insertion axis <b>5</b><i>a </i>and holding the needle <b>12</b>, is mounted on the second rotation guide <b>4</b>. As shown in <figref idref="DRAWINGS">FIGS. 1A, 1B, 2A and 2B</figref>, an element described as mounted onto another element means that such elements are rigidly connected. The term “rigidly connected” is intended to mean that the connection results in there being no relative motion between the connected elements except for minor tolerances.
0078<figref idref="DRAWINGS">FIG. 1C</figref> shows a bottom view of base body <b>2</b> of the apparatus main body <b>1</b>. The base body <b>2</b> is a ring shaped structure configured to support on its upper surface the first rotation guide <b>3</b>. On the base body <b>2</b>, a cylindrical fitting portion <b>2</b><i>a </i>is formed as cylindrical opening substantially concentric with an axial center thereof. A bottom surface <b>2</b><i>c </i>of the base body <b>2</b> is provided with a groove <b>2</b><i>b</i>. The cylindrical fitting portion <b>2</b><i>a </i>serves to engage the apparatus main body <b>1</b> onto an attachment.
0079The second rotation guide <b>4</b> is a mechanism rotatable about an axis <b>9</b>. The axis <b>9</b> and the second rotation guide <b>4</b> including the needle holder <b>5</b> can be rotated about the axis <b>8</b> by the first rotation guide <b>3</b>. The axis <b>8</b> and the axis <b>9</b> are designed to cross each other and form an angle θ. The angle θ is set to satisfy the condition of 0°<θ<90°, preferably, θ=15° to 20°, for example. The first and second rotation guides <b>3</b> and <b>4</b> each include a driving unit that causes rotational displacement and a detecting unit for detecting the rotational displacement. Rotational displacement between the first and second rotary guides <b>3</b> and <b>4</b> may also be determined by tracking markers <b>16</b>. Tracking markers <b>16</b> are fiducial markers which can be mounted on two or more of the base body <b>2</b>, the first rotation guide <b>3</b>, and the second rotation guide <b>4</b>. The tracking markers can be designed to be visible under magnetic resonance imaging and/or computerized tomographic imaging, or visible other imaging modality. A mix of different tracking markers may be used for providing visibility under plural imaging modalities. The tracking markers may be set along the radius the rotation guides and/or base body <b>2</b>, at predetermined angles, e.g., at 0 degrees, 120 degrees and 240 degrees of radially marked surface on the top surface of the base body <b>2</b> and rotation guides <b>3</b> and/or <b>4</b>.
0080An electrical component box <b>7</b> includes not-shown elements, such as a circuit board including a power supply unit that supplies power to the driving units and the detecting units, and a signal processing unit for processing signals coming from the detecting units. The electrical component box <b>7</b> also provides communication interface (electronic connections) for one or more of the driving units and the detecting units so that commands can be received from an external device, such as a computer. The electrical component box <b>7</b> may also include programmable logic for use with a programmable logic devices (PDL) or application specific integrated circuit (ASIC) devices used for controlling needle positioning with the driving units. The electrical component box <b>7</b>A is connected to non-illustrated control unit (e.g. a computer) that controls the electronic components included in the electrical component box <b>7</b>.
0081<figref idref="DRAWINGS">FIG. 2A</figref> is a schematic cross-sectional view of the apparatus main body <b>1</b> taken along a sectional plane including the axes <b>8</b> and <b>9</b> in <figref idref="DRAWINGS">FIG. 1A or 1B</figref>. <figref idref="DRAWINGS">FIG. 2B</figref> is an enlarged view of a dashed-line region A shown in <figref idref="DRAWINGS">FIG. 2A</figref>. In <figref idref="DRAWINGS">FIG. 2A</figref>, the bottom surface <b>2</b><i>c </i>of the base body <b>2</b> is a flat surface. The first rotary guide <b>3</b> and the second rotary guide <b>3</b> are mounted at a predetermined angle with respect to each other, such that the axes <b>8</b> and <b>9</b> intersect at a point referred herein as the remote center of motion (RCM) <b>11</b>. When the needle <b>12</b> is inserted along the insertion axis <b>5</b><i>a </i>of the needle holder <b>5</b>, the needle <b>12</b> passes through the remote center of motion (RCM) <b>11</b> regardless of the rotational displacement of the first rotation guide <b>3</b> with respect to the second rotation guide <b>4</b>.
0082Referring next to <figref idref="DRAWINGS">FIG. 2B</figref>, the driving unit and the detecting unit disposed in each of the first and second rotation guides <b>3</b> and <b>4</b> will be described. The present embodiment includes a piezoelectric actuator as the driving unit and an optical encoder as the detecting unit disposed in each of the first and second rotation guides <b>3</b> and <b>4</b>. Referring to <figref idref="DRAWINGS">FIG. 2B</figref>, a first support member <b>24</b> is fixed to the base body <b>2</b>. The first rotation guide <b>3</b> can rotate smoothly about the axis <b>8</b> with a bearing <b>26</b> mounted on the first support member <b>24</b>. The first rotation guide <b>3</b> and a second support member <b>25</b> are fixed to the cover <b>10</b>. The second rotation guide <b>4</b> can rotate smoothly about the axis <b>9</b> with a bearing <b>27</b> mounted on the second support member <b>25</b>.
0083Next, the configuration of the piezoelectric actuator will be described. An elastic member <b>20</b> is attached to the each of the first rotation guide <b>3</b> and the second support member <b>25</b>, with the directions of rotation about the axes <b>8</b> and <b>9</b> restrained. An electromechanical energy transducer <b>22</b> is firmly fixed to each elastic member <b>20</b> with an adhesive (not shown). The elastic member <b>20</b> and the electromechanical energy transducer <b>22</b> are pushed against a movable object <b>21</b> fixed to the first support member <b>24</b> or the second rotation guide <b>4</b> by a pressure unit <b>23</b> provided in the first rotation guide <b>3</b> or the second support member <b>25</b>. With this configuration, the elastic member <b>20</b> and the movable object <b>21</b> can be frictionally driven relative to each other in the direction of rotation by applying a voltage with a predetermined frequency band to the electromechanical energy transducer <b>22</b> to vibrate the elastic member <b>20</b> in an out-of-plane direction.
0084The first rotation guide <b>3</b> includes an optical encoder (not shown), which is one component of the detecting unit, and the first support member <b>24</b> includes an optical scale (not shown), which is one component of the detecting unit, at a radial position opposed thereto. Likewise, the second support member <b>25</b> includes an (not shown) optical encoder, which is one component of the detecting unit, and the second rotation guide <b>4</b> includes an optical scale (not shown), which is one component of the detecting unit, at a radial position opposed thereto. This configuration allows detection of displacement in rotational angles of the first and second rotation guides <b>3</b> and <b>4</b> about the axes <b>8</b> and <b>9</b>, respectively.
0085A material of the driving units will be described. The first and second support members <b>24</b> and <b>25</b> and the first and second rotation guides <b>3</b> and <b>4</b> may be formed of metal, such as an aluminum alloy, rigid plastic, such as polyether ether ketone (PEEK), or ceramic, whose X-ray absorption coefficients are relatively low. Materials having low X-ray absorption coefficients are preferable because the imaging of the support member's external dimension accuracy directly influences the accuracy of the arrival position of the medical instrument with respect to the object target of needle placement (e.g., a tumor). The elastic members <b>20</b> may be made of metal, such as an aluminum alloy, or fine ceramic, such as alumina, silicon nitride, or partially stabilized zirconia (PSZ), whose X-ray absorption coefficients are also relatively low. The electromechanical energy transducers <b>22</b> may be formed of piezoelectric ceramic, such as lead zirconate titanate or barium titanate. The material of the movable objects <b>21</b> may be selected to have stable sliding characteristic and abrasion-resistant characteristic with respect to the elastic member <b>20</b>, for example, a magnesium-based aluminum alloy whose surface is made rigid by alumite treatment or nitriding treatment and a fiber-reinforced resin, such as polyether ether ketone (PEEK) containing carbon fibers or the like. The pressure units <b>23</b> may be formed of non-magnetic metal, such as phosphor bronze, or high-toughness ceramic, such as partially stabilized zirconia (PSZ).
0086The apparatus main body <b>1</b> includes a plurality of markers <b>16</b> (fiduciary markers) each fixed to a pedestal <b>17</b> to detect the position and posture of the apparatus main body <b>1</b> in a CT bore. In the present embodiment, as shown in <figref idref="DRAWINGS">FIGS. 1A and 1B</figref>, five markers on the base body <b>2</b>, four markers on the second rotation guide <b>4</b>, and two markers on the side of the needle holder <b>5</b>, eleven in total, are disposed to allow detection of the posture of the apparatus main body <b>1</b>, the posture of the second rotation guide <b>4</b>, and the position of the needle holder <b>5</b>. The material of the fiducial markers will depend on the modality in which the needle placement manipulator will be used. For installation of the apparatus main body <b>1</b> in a CT scanner, the markers <b>16</b> may be formed of gypsum, resin, ceramic, an aluminum alloy, or another material with a CT value of about 1,000.
0087Referring to <figref idref="DRAWINGS">FIG. 3</figref> to <figref idref="DRAWINGS">FIGS. 5A and 5B</figref> and <figref idref="DRAWINGS">FIGS. 10A to 10C</figref>, the configuration of a needle placement manipulator <b>51</b> for determining the direction of the needle <b>12</b> in the apparatus main body <b>1</b> relative to the target portion and a workflow for puncture with the needle <b>12</b> will be described. <figref idref="DRAWINGS">FIG. 3</figref> is a schematic perspective view of the needle placement manipulator <b>51</b> of the present embodiment. <figref idref="DRAWINGS">FIG. 4A</figref> is a schematic perspective view of an attachment <b>52</b>, and <figref idref="DRAWINGS">FIG. 4B</figref> is a schematic perspective view of a cross section of the attachment <b>52</b>. In the present embodiment, <figref idref="DRAWINGS">FIG. 3</figref> shows the attachment <b>52</b> combined with the apparatus main body <b>1</b> to form the needle placement manipulator <b>51</b>. In the drawings, the attachment <b>52</b> includes a fixed portion <b>53</b> and a movable portion <b>54</b>. The fixed portion <b>53</b> and the movable portion <b>54</b> respectively include spherical guides <b>53</b><i>c </i>and <b>54</b><i>c </i>so that the movable portion <b>54</b> can change in posture relative to the fixed portion <b>53</b> along the spherical guide <b>53</b><i>c</i>. The center of spherical surfaces including the spherical guides <b>53</b><i>c </i>and <b>54</b><i>c </i>may coincide with the remote center of motion (RCM) <b>11</b>.
0088The fixed portion <b>53</b> includes a mount portion with a mount surface. The bottom of the mount portion includes a curved mount surface <b>53</b><i>a </i>which allows stable mounting of the attachment <b>52</b> onto a patient by following the shape of the body surface of the patient. The movable portion <b>54</b> has a ridge key <b>54</b><i>b</i>. A groove <b>2</b><i>b </i>(shown in <figref idref="DRAWINGS">FIG. 1C</figref>) formed in the bottom of the apparatus main body <b>1</b> is shaped to be fitted with the ridge key <b>54</b><i>b</i>. The cylindrical fitting portion <b>2</b><i>a </i>(<figref idref="DRAWINGS">FIG. 1C</figref>) provided in base body <b>2</b> of the apparatus main body <b>1</b> is fitted to an axial fitting portion <b>54</b><i>a </i>of the attachment <b>52</b>, so that the position and posture of the apparatus main body <b>1</b> relative to the attachment <b>52</b> can be fixed.
0089A method for changing the posture of the movable portion <b>54</b> with respect to the fixed portion <b>53</b> will be described. The movable portion <b>54</b> can be changed in posture relative to the fixed portion <b>53</b> along the spherical guides <b>53</b><i>c </i>and <b>54</b><i>c </i>about the remote center of motion (RCM) it After the posture of the movable portion <b>54</b> is changed, the movable portion <b>54</b> can be fixed relative to the fixed portion <b>53</b> using an electromechanical actuator unit <b>103</b><i>d </i>or a mechanical knurled knob <b>116</b>, which may be referred herein as a fixing unit, and will be described later in more detail. To prevent the movable portion <b>54</b> from being disengaged from the fixed portion <b>53</b>, such as when the needle placement manipulator is used upwards (in a position opposite to the direction of gravity), the attachment <b>52</b> may have a spring, a wire, a magnet, or the like as appropriate to urge the movable portion <b>54</b> against the fixed portion <b>53</b>.
0090<figref idref="DRAWINGS">FIGS. 5A and 5B</figref> illustrate a simulated puncture of a needle <b>12</b> to a target tissue <b>14</b> using the needle placement manipulator <b>51</b> disposed on a patient's skin <b>15</b>. In this case, the remote center of motion (RCM) <b>11</b> may be set on the skin <b>15</b>, and the puncture point may not move regardless of the displacement of the first and second rotation guides <b>3</b> and <b>4</b> with respect to each other. <figref idref="DRAWINGS">FIG. 5A</figref> illustrates a state in which the intended target tissue <b>14</b> is out of coverage, so that the tip of needle <b>12</b> cannot be brought to the target tissue <b>14</b> even if the first and second rotation guides <b>3</b> and <b>4</b> are rotated to a maximum inclination. However, by changing the posture of the movable portion <b>54</b> using the attachment <b>52</b> of the present disclosure, the target tissue <b>14</b> can be brought within the coverage, so that the needle <b>12</b> can be brought to the target tissue <b>14</b>, as illustrated in <figref idref="DRAWINGS">FIG. 5B</figref>. Whether the target tissue <b>14</b> is within the coverage of the apparatus main body <b>1</b> is determined using the following procedure, and the needle <b>12</b> is directed to the target tissue <b>14</b>. First, the posture of the movable portion <b>54</b> is determined and fixed at an initial step of mounting the needle placement manipulator <b>51</b> onto the body of a patient. Subsequently, whether the coverage of the apparatus main body <b>1</b> includes the target tissue <b>14</b> is determined through calculation based on a CT image using the fiducial markers <b>16</b> provided on the apparatus main body <b>1</b>. If it is determined that the target tissue <b>14</b> is within the coverage, planning for bringing the needle <b>12</b> to the target tissue <b>14</b> is executed to displace the first and second rotation guides <b>3</b> and <b>4</b> to predetermined angles, thereby directing the needle <b>12</b> to the direction of the target tissue <b>14</b>. If it is determined that the target tissue <b>14</b> is not within the coverage, the movable portion <b>54</b> of the attachment <b>52</b> is operated to expand the coverage of the needle placement manipulator <b>51</b>.
0091The basis for expanding the coverage of the needle placement manipulator <b>51</b> using the attachment <b>52</b> of the present disclosure will be described with reference to <figref idref="DRAWINGS">FIGS. 10A to 10C</figref>. <figref idref="DRAWINGS">FIG. 10A</figref> illustrates the initial coverage of the needle placement manipulator <b>51</b> without the use of the attachment <b>52</b>. The initial coverage, which determined by rotating the first and second rotation guides <b>3</b> and <b>4</b> individually in the circumferential direction, is a conical region <b>108</b> enclosed by a dashed-line region with an apical angle of 4θ and with the remote center of motion <b>11</b> as a vertex, where θ is an angle formed by the axes <b>8</b> and <b>9</b> of the first and second rotation guides <b>3</b> and <b>4</b>, respectively. That is, <figref idref="DRAWINGS">FIG. 10A</figref> shows the axis <b>8</b> and axis <b>9</b> of the rotation guides (<b>3</b>, <b>4</b>) intersect at the remote center of motion (RCM: <b>11</b>), and the rotation guides (<b>3</b>, <b>4</b>) rotate to position the needle holder (<b>5</b>) such that the axis of the needle holder (insertion axis <b>5</b><i>a</i>) traces a conical region of coverage, the conical region of coverage having the apex thereof at the RCM <b>11</b> and the base thereof in a direction towards the subject of needle placement (<b>14</b>).
0092<figref idref="DRAWINGS">FIG. 10B</figref> illustrates a state in which the posture of the apparatus main body <b>1</b> is inclined (adjusted) by an angle δ using the attachment <b>52</b>. In this state shown in <figref idref="DRAWINGS">FIG. 10B</figref>, the entire conical coverage <b>108</b> is inclined by the angle δ, as compared to the position shown in <figref idref="DRAWINGS">FIG. 10A</figref>. If the attachment <b>52</b> can incline the movable portion <b>54</b> by an angle δ across the entire circumferential region of the spherical guide <b>54</b><i>c</i>, the coverage of the needle placement manipulator <b>51</b> increases to a conical region <b>109</b> enclosed by the dashed line with an apical angle of 4θ+2δ and with the remote center of motion <b>11</b> as a vertex, as illustrated in <figref idref="DRAWINGS">FIG. 10C</figref>. As a result, the use of the attachment <b>52</b> effectively increases the coverage of the needle placement manipulator <b>51</b> to a conical range 4θ+2δ without changing the initial position of the apparatus main body <b>1</b> or the mount surface <b>53</b><i>a </i>with respect to the patient, but rather by operating only the movable portion <b>54</b> along the spherical guide <b>53</b><i>c</i>, as illustrated by the arrows in <figref idref="DRAWINGS">FIG. 5B</figref>. Therefore, <figref idref="DRAWINGS">FIGS. 10B and 10C</figref> show how the guide portion (<b>53</b><i>c</i>, <b>54</b><i>c</i>) changes the inclination of the rotary mechanism such that the axis of the needle holder intersects an insertion target (tissue <b>14</b>) located outside of the initial conical region of coverage <b>108</b>.
0093The attachment <b>52</b> including the spherical guides <b>53</b><i>c </i>and <b>54</b><i>c </i>illustrated in <figref idref="DRAWINGS">FIG. 3</figref> to <figref idref="DRAWINGS">FIGS. 5A and 5B</figref> is one exemplary illustration, which may be modified to have other configurations. The details of exemplary modifications will be described with reference to <figref idref="DRAWINGS">FIG. 6</figref> to <figref idref="DRAWINGS">FIGS. 11A and 10</figref>. <figref idref="DRAWINGS">FIG. 6</figref> is a schematic perspective view of a needle placement manipulator <b>101</b> including spherical guides of the present embodiment. <figref idref="DRAWINGS">FIG. 7A</figref> is a schematic perspective view of the attachment <b>102</b> excluding the apparatus main body <b>1</b>, and <figref idref="DRAWINGS">FIG. 7B</figref> is a schematic perspective view of a cross section of the attachment <b>102</b>. In <figref idref="DRAWINGS">FIG. 6</figref>, the attachment <b>102</b> is combined with the apparatus main body <b>1</b> to constitute the needle placement manipulator <b>101</b>. In the drawings of <figref idref="DRAWINGS">FIGS. 7A and 7B</figref>, the attachment <b>102</b> includes a fixed portion <b>103</b> and a movable portion <b>104</b>. The movable portion <b>104</b> includes a cylindrical fitting portion <b>104</b><i>a </i>configured to fit with the base body <b>2</b> of the apparatus main body <b>1</b>. The fixed portion <b>103</b> includes an actuator unit <b>103</b><i>d. </i>
0094<figref idref="DRAWINGS">FIG. 8A</figref> is a cross-sectional view of the needle placement manipulator <b>101</b> taken along a cross section including the actuator unit <b>103</b><i>d</i>, and <figref idref="DRAWINGS">FIG. 8B</figref> is an enlarged view of a dashed-line region B. The fixed portion <b>103</b> includes a spherical guide <b>103</b><i>b</i>, and the movable portion <b>104</b> includes a spherical guide <b>104</b><i>b</i>. The movable portion <b>104</b> can change in posture along the spherical guide <b>103</b><i>b </i>relative to the fixed portion <b>103</b>. In this case, the center of the spherical surfaces including the spherical guides <b>103</b><i>b </i>and <b>104</b><i>b </i>coincide with the remote center of motion (RCM) <b>11</b>. The fixed portion <b>103</b> includes three mount portions <b>103</b><i>a</i>. The bottom of each mount portion <b>103</b><i>a </i>has a curved mount surface <b>103</b><i>c </i>(<figref idref="DRAWINGS">FIG. 8A</figref>) that follows the shape of the body surface of the patient to allow stable mounting. In the present embodiment, the bottom surface <b>2</b><i>c </i>of the base body <b>2</b> of the apparatus main body <b>1</b> can be fixed to the movable portion <b>104</b> to prevent the mutual interference between the apparatus main body <b>1</b> and the attachment <b>102</b> when the posture of the movable portion <b>104</b> is changed.
0095Next, a method for changing the posture of the movable portion <b>104</b> will be described with reference to <figref idref="DRAWINGS">FIGS. 8A and 8B</figref>. In the drawings, a layered piezoelectric element <b>105</b> is disposed in the actuator unit <b>103</b><i>d</i>. A hemispherical protrusion <b>106</b> is joined to an end of the layered piezoelectric element <b>105</b>. The protrusion <b>106</b> is pushed against the spherical guide <b>104</b><i>b </i>by a compression coil spring <b>107</b> disposed in series with the layered piezoelectric element <b>105</b>. When the layered piezoelectric element <b>105</b> is not energized, the posture of the movable portion <b>104</b> is fixed due to the friction between the protrusion <b>106</b> and the spherical guide <b>104</b><i>b</i>. When an alternating current voltage is applied to the layered piezoelectric element <b>105</b>, the friction between the protrusion <b>106</b> and the spherical guide <b>104</b><i>b </i>is decreased to allow the movable portion <b>104</b> to be freely moved along the spherical guide <b>103</b><i>b</i>. Therefore, the actuator unit <b>103</b><i>d </i>effectively functions as brake (or a clutch) configured to brake (stop or inhibit) movement of the movable portion <b>104</b> relative to the fixed portion <b>103</b>. The actuator unit <b>103</b><i>d </i>may also be referred to as a brake unit. To prevent the movable portion <b>104</b> from being detached from the fixed portion <b>103</b>, for example, for example, when gravity acts on the attachment <b>102</b> vertically downward in the plane of the drawing, a spring, a wire, a magnet, or the like may be provided as appropriate to urge the movable portion <b>104</b> against the fixed portion <b>103</b>.
0096<figref idref="DRAWINGS">FIGS. 9A and 9B</figref> illustrate simulated puncture of the target tissue <b>14</b> using the needle placement manipulator <b>101</b> placed on the patient's skin <b>15</b>. In that case, the remote center of motion (RCM) <b>11</b> may be set on the skin <b>15</b>, and the puncture point may not move regardless of the displacement (rotation) of the first and second rotation guides <b>3</b> and <b>4</b>. <figref idref="DRAWINGS">FIG. 9A</figref> illustrates a state in which the intended target tissue <b>14</b> is out of coverage, so that the tip of needle <b>12</b> cannot be brought to the target tissue <b>14</b> even if the first and second rotation guides <b>103</b><i>b </i>and <b>104</b><i>b </i>are rotated. However, by changing the posture of the movable portion <b>104</b> using the attachment <b>102</b> of the present disclosure, the target tissue <b>14</b> can be brought within the coverage, so that the needle <b>12</b> can be brought to the target tissue <b>14</b>, as illustrated in <figref idref="DRAWINGS">FIG. 9B</figref>. Whether the target tissue <b>14</b> is within the coverage of the apparatus main body <b>1</b> is determined using the following procedure, and the needle <b>12</b> is directed to the target tissue <b>14</b>. After the posture of the movable portion <b>104</b> is determined, the actuator unit <b>103</b><i>d </i>is brought to a non-energized state to fix the movable portion <b>104</b>. Subsequently, whether the coverage of the apparatus main body <b>1</b> includes the target tissue <b>14</b> is determined through calculation based on a CT image using the markers <b>16</b> provided on the apparatus main body <b>1</b>, and if it is determined that the target tissue <b>14</b> is within the coverage, planning for bringing the needle <b>12</b> to the target tissue <b>14</b> is executed to displace the first and second rotation guides <b>3</b> and <b>4</b> to predetermined angles, thereby directing the needle <b>12</b> to the direction of the target tissue <b>14</b>.
0097The manner of expanding the coverage of the needle placement manipulator <b>101</b> using the attachment <b>102</b> of the present disclosure will be described again with reference to <figref idref="DRAWINGS">FIGS. 10A to 10C</figref>. <figref idref="DRAWINGS">FIG. 10A</figref> illustrates the coverage of the needle placement manipulator <b>101</b>. The coverage determined by rotating the first and second rotation guides <b>3</b> and <b>4</b> individually in the circumferential direction is a conical region <b>108</b> enclosed by a dashed-line region with an apical angle of 4θ and with the remote center of motion <b>11</b> as a vertex, where θ is an angle formed by the first and second rotation guides <b>3</b> and <b>4</b>. <figref idref="DRAWINGS">FIG. 10B</figref> illustrates a state in which, when the posture of the apparatus main body <b>1</b> is inclined by an angle δ using the attachment <b>102</b>, the conical coverage <b>108</b> is inclined by the angle δ. If the attachment <b>102</b> can incline the movable portion <b>104</b> by an angle δ across the entire circumferential region, the coverage of the needle placement manipulator <b>101</b> increases to a conical region <b>109</b> enclosed by the dashed line with an apical angle of 4θ+2δ and with the remote center of motion <b>11</b> as a vertex illustrated in <figref idref="DRAWINGS">FIG. 10C</figref>.
0098Having described the configuration of the attachment <b>102</b> with the actuator unit <b>103</b><i>d</i>, the configuration illustrated in <figref idref="DRAWINGS">FIGS. 11A and 11B</figref> may be employed. <figref idref="DRAWINGS">FIG. 11A</figref> is a schematic perspective view of a needle placement manipulator <b>111</b>, and <figref idref="DRAWINGS">FIG. 11B</figref> is an enlarged view of a dashed-line region C. Descriptions of components given the same reference signs will be omitted. In the drawings of <figref idref="DRAWINGS">FIGS. 11A and 11B</figref>, reference sign <b>112</b> denotes an attachment. In this case, the attachment <b>112</b> is combined with the apparatus main body <b>1</b> to constitute the needle placement manipulator <b>111</b>. A fixed portion <b>113</b> of the attachment <b>112</b> has a clearance <b>115</b> at part in the circumferential direction and includes an internal thread <b>113</b><i>a </i>(internal threaded through hole) perpendicular to the clearance <b>115</b>. The fixed portion <b>113</b> is configured such that the clearance <b>115</b> can be decreased by inserting an external thread <b>116</b><i>a </i>(a threaded stud) of a knurled knob <b>116</b> into the internal thread <b>113</b><i>a</i>. The knurled knob <b>116</b> provides a gripping surface for tightening or loosening the clearance <b>115</b>. This configuration allows the posture of the movable portion <b>104</b> to be changed along the spherical guide by loosening the threads <b>113</b><i>a </i>and <b>116</b><i>a </i>and the posture of the movable portion <b>104</b> to be fixed by tightening the threads <b>113</b><i>a </i>and <b>116</b><i>a</i>. To prevent the movable portion <b>104</b> from being disengaged from the fixed portion <b>113</b>, for example, when gravity acts on the attachment <b>112</b> vertically downward in the plane of the drawing, a spring, a wire, a magnet, or the like may be provided as appropriate to urge the movable portion <b>104</b> against the fixed portion <b>113</b>.
0099In the present embodiment, even if it is found that the target tissue <b>14</b> is out of the coverage of the needle placement manipulator <b>111</b> after the needle placement manipulator <b>111</b> is placed on the body of the patient, the use of either the attachment <b>52</b>, <b>102</b>, or <b>112</b> combined with the apparatus main body <b>1</b> allows the coverage to be corrected by changing the posture of the movable portion <b>54</b> or <b>104</b>. In other words, the posture of the needle placement manipulator <b>51</b>, <b>101</b>, or <b>111</b> can be changed so that the target tissue <b>14</b> falls within the necessary coverage. Changing the posture of the needle placement manipulator using the attachment described in the present embodiment eliminates the need to remove the attachment and the needle placement manipulator from the surface of the body of the patient when change in coverage is needed. This can omit troublesome treatment for maintaining the sterilized state of the attachment and the needle placement manipulator, leading to shorter operation time. The present embodiment enables not only to correct the coverage using the attachment so that the target tissue <b>14</b> falls within the coverage but also to change the posture using the attachment, with the target tissue included in the coverage, to prevent the interference between the bore of the imaging modality and the apparatus main body <b>1</b>.
0100The present embodiment also has the effect of preventing the puncture point on the patient's skin set by planning from moving even if the posture is changed using the attachment by making the center of the spherical guides of the attachment and the remote center of motion to coincide at one point.
0101Although the present disclosure has been described as related to a needle placement manipulator whose apparatus main body has the remote center of motion (RCM) mechanism, it is to be understood that the apparatus main body need only include a guide for positioning the needle insertion axis and that the apparatus main body may have any configuration. It should also be understood that the workflow for determining whether the target tissue is within the coverage of the apparatus main body is given for mere illustration and that application of the present disclosure is not limited thereto.
0102Although the present embodiment has been described as applied to a configuration in which a piezoelectric actuator is used as the driving unit, and an optical encoder is used as the detecting unit, it is to be understood that the present disclosure is not limited thereto. Any other actuator and any other sensor may be respectively used as the driving unit and the detecting unit. The rotational displacement of the first and second rotation guides <b>3</b> and <b>5</b> may be manually adjusted without using an actuator and a sensor.
0103Although the present embodiment has been described using an example in which a layered piezoelectric element in the actuator unit is used to change the posture of the movable portion of the attachment, and the friction when changing the posture is reduced by applying an alternating voltage to the layered piezoelectric element to vibrate it, this is given for mere illustration. For example, by pushing an elastic member similar to the elastic member <b>20</b> against the spherical guide and applying an alternating voltage to the electromechanical energy transducer <b>22</b> firmly fixed to the elastic member to excite a standing wave on the contact surface of the elastic member, the same advantageous effect can be achieved. Furthermore, by increasing the number of elastic members for pressure, for example, by using three elastic members and generating a traveling wave on the contact surfaces of the elastic members, the movable portion of the attachment can be positioned at any posture along the spherical guide.
0104Although the present embodiment has been described using a CT scanner as a modality for visualization, the present disclosure is not limited thereto. For example, the present disclosure may be applied to the configuration of a nuclear magnetic resonance imaging (MRI) diagnostic apparatus. In this case, non-magnetic metal, resin, or ceramic may be used as a material of the needle placement manipulator and the attachment. In that case, a material of the markers may be a substance containing hydrogen atoms, such as an aqueous copper sulfate solution. In using the MRI, an RF coil for transmitting and receiving signals may be disposed below or in the vicinity of the attachment, as will be illustrated in the embodiments described below.
0105Although the present embodiment has been described as related to a configuration in which the center of the spherical guides coincides with the remote center of motion (RCM), the present disclosure is not limited to the configuration. The coverage correction range may be increased more without making the center of the spherical guides coincide with the remote center of motion (RCM), as illustrated in fourth and fifth embodiments described below.
Second Embodiment
0106Referring to <figref idref="DRAWINGS">FIGS. 7A and 7B</figref> and <figref idref="DRAWINGS">FIGS. 12 to 15B</figref>, a second embodiment of the present disclosure will be described. Where the same components as those of the above-described embodiment are given the same reference signs, detailed descriptions thereof will be omitted. In the present embodiment, an X-ray computed tomography (CT) scanner is used to visualize the inside of the body, medical devices, medical-device guide devices, etc.
0107<figref idref="DRAWINGS">FIG. 12</figref> is a schematic perspective view of a needle placement manipulator <b>121</b> according to a second embodiment of the present disclosure. The configuration of the apparatus main body <b>1</b> of the needle placement manipulator <b>121</b> is the same as the configuration of the above-described first embodiment. In the present embodiment, an attachment <b>122</b> is combined with the apparatus main body <b>1</b> to constitute the needle placement manipulator <b>121</b>. <figref idref="DRAWINGS">FIG. 13</figref> is a schematic perspective view of the attachment <b>122</b> single body. <figref idref="DRAWINGS">FIG. 14A</figref> is a schematic cross-sectional view of the attachment <b>122</b> taken along a plane passing through an actuator unit <b>123</b><i>d </i>provided at the attachment <b>122</b>. <figref idref="DRAWINGS">FIG. 14B</figref> is an enlarged view of a dashed-line region D in <figref idref="DRAWINGS">FIG. 14A</figref>. In the drawings, the attachment <b>122</b> includes a fixed portion <b>123</b> and a movable portion <b>124</b>, as in the first embodiment, and the fixed portion <b>123</b> includes three mount portions <b>103</b><i>a</i>. The movable portion <b>124</b> is configured to rotate relative to the fixed portion <b>123</b> with a rotatable bearing arranged therebetween, as described below. Between the fixed portion <b>123</b> and the movable portion <b>124</b>, a plurality of balls <b>126</b> are disposed in the circumferential direction along a groove to constitute a bearing by bonding a fastener member <b>125</b> to the movable portion <b>124</b> after the balls <b>126</b> are disposed in the groove. The use of the bearing allows the movable portion <b>124</b> and the fastener member <b>125</b> to smoothly rotate about a rotational axis <b>127</b> more than 360 degrees without wobbling movement. The movable portion <b>124</b> includes a ring-shaped holding portion <b>124</b><i>a</i>. By fitting the base body <b>2</b> of apparatus main body <b>1</b> on the holding portion <b>124</b><i>a</i>, the apparatus main body <b>1</b> can be fixed to the movable portion <b>124</b>. The ring-shaped holding portion <b>124</b><i>a </i>is inclined (or is configured to be inclined) at a predetermined angle δ relative to the horizontal plane, and the central axis <b>128</b> of the holding portion <b>124</b><i>a </i>intersects the rotational axis <b>127</b> at an intersection point to form a remote center of motion (RCM) <b>129</b>. The remote center of motion <b>129</b> of the attachment <b>122</b> may coincide with the remote center of motion <b>11</b> of the apparatus main body <b>1</b>.
0108The fixed portion <b>123</b> includes an actuator unit <b>123</b><i>d</i>. In the actuator <b>123</b><i>d</i>, a hemispherical protrusion <b>106</b> is pushed against the side of the fastener member <b>125</b> by a piezoelectric element <b>105</b> and a compression coil spring <b>107</b>. While the layered piezoelectric element <b>105</b> is not energized, the posture of the movable portion <b>124</b> is fixed due to the friction between the protrusion <b>106</b> and the fastener member <b>125</b>. When an alternating current voltage is applied to the layered piezoelectric element <b>105</b>, the friction between the protrusion <b>106</b> and the fastener member <b>125</b> is decreased to allow the movable portion <b>124</b> to be rotated about the rotational axis <b>127</b> via the bearing.
0109<figref idref="DRAWINGS">FIGS. 15A and 15B</figref> illustrate simulated puncture of the target tissue <b>14</b> using the needle placement manipulator <b>121</b> placed on the patient's skin <b>15</b>. In this case, the remote center of motion (RCM) <b>11</b> may be set on the skin <b>15</b>, and the remote center of motion (RCM) <b>129</b> may or may not coincide with RCM <b>11</b>, but the puncture point may not move regardless of the displacement of the first and second rotation guides <b>3</b> and <b>4</b>. <figref idref="DRAWINGS">FIG. 15A</figref> illustrates a state in which the intended target tissue <b>14</b> is out of coverage, so that the tip of needle <b>12</b> cannot be brought to the target tissue <b>14</b> even if the first and second rotation guides <b>103</b><i>b </i>and <b>104</b><i>b </i>are rotated to a maximum inclination. However, by changing the posture of the movable portion <b>124</b> using the attachment <b>122</b> of the present disclosure, the target tissue <b>14</b> can be brought within the coverage, so that the needle <b>12</b> can be brought to the target tissue <b>14</b>, as illustrated in <figref idref="DRAWINGS">FIG. 15B</figref>. A method for determining whether the target tissue <b>14</b> is within the coverage of the apparatus main body <b>1</b> is the same as the method of the first embodiment, and a detailed description thereof will be omitted.
0110The coverage of the needle placement manipulator <b>121</b> can be expanded by using the attachment <b>122</b> of the present disclosure, as in the first embodiment. The use of the attachment <b>122</b> expands the coverage to the conical region <b>109</b> enclosed by the dashed line with the remote center of motion <b>11</b> as a vertex and with an apical angle 4θ+2δ, as illustrated in <figref idref="DRAWINGS">FIG. 10C</figref>.
0111In the present embodiment, even if it is found that the target tissue <b>14</b> is out of the coverage of the needle placement manipulator <b>121</b> after the needle placement manipulator <b>121</b> is placed on the body of the patient, the combined use of the attachment <b>122</b> and the apparatus main body <b>1</b> allows the coverage to be corrected by rotating the movable portion <b>124</b> to change the posture of the apparatus main body <b>1</b>. In other words, the posture of the needle placement manipulator <b>121</b> can be changed so that the target tissue <b>14</b> falls within the coverage. Changing the posture of the needle placement manipulator <b>121</b> using the attachment <b>122</b> described in the present embodiment eliminates the need to remove the attachment <b>122</b> and the needle placement manipulator <b>121</b> from the surface of the body of the patient when change in coverage is needed. This allows the sterilized state of the attachment <b>122</b> and the needle placement manipulator <b>121</b> to be kept, leading to shorter operation time. The present embodiment enables not only to correct the coverage using the attachment <b>122</b> so that the target tissue <b>14</b> falls within the coverage but also to change the posture using the attachment <b>122</b> to prevent, for example, the interference between the bore and the apparatus main body <b>1</b>.
0112The present embodiment also has the effect of preventing the puncture point on the patient's skin set by planning from moving even if the posture is changed using the attachment by making the center of the spherical guides of the attachment and the remote center of motion coincide.
0113Although the present disclosure has been described as related to a needle placement manipulator whose apparatus main body has the remote center of motion (RCM) mechanism, it is to be understood that the apparatus main body need only include a guide for positioning the needle insertion axis and that the apparatus main body may have any configuration.
0114It should also be understood that the workflow for determining whether the target tissue is within the coverage of the apparatus main body is given for mere illustration and that application of the present disclosure is not limited thereto.
0115Although the present embodiment has been described as applied to a configuration in which a piezoelectric actuator is used as the driving unit, and an optical encoder is used as the detecting unit, it is to be understood that the present disclosure is not limited thereto. Any other actuator and any other sensor may be respectively used as the driving unit and the detecting unit. The rotational displacement of the first and second rotation guides may be manually adjusted without using an actuator and a sensor.
0116Although the present embodiment has been described using an example in which a layered piezoelectric element in the actuator unit is used to change the posture of the movable portion of the attachment, and the friction when changing the posture is reduced by applying an alternating voltage to the layered piezoelectric element to vibrate it, this is given for mere illustration. For example, a unit similar to the piezoelectric actuator illustrated in <figref idref="DRAWINGS">FIG. 2B</figref> may be used to rotate the movable portion about the rotational axis <b>127</b>.
0117Although the present embodiment has been described using a CT scanner as a modality for visualization, the present disclosure is not limited thereto. For example, the present disclosure may be applied to the configuration of a nuclear magnetic resonance imaging (MRI) diagnostic apparatus. In this case, non-magnetic metal, resin, or ceramic may be used as a material of the needle placement manipulator and the attachment. In that case, a material of the markers may be a substance containing hydrogen atoms, such as an aqueous copper sulfate solution. In using the MRI, an RF coil for transmitting and receiving signals may be disposed below or in the vicinity of the attachment, as will be illustrated in the embodiments described below.
0118Although the present embodiment has been described as related to a configuration in which the center of the spherical guides coincides with the remote center of motion (RCM), the present disclosure is not limited to the configuration. The coverage correction range may be increased more without making the center of the spherical guides coincide with the remote center of motion (RCM), as illustrated in fourth and fifth embodiments described below.
Third Embodiment
0119Referring to <figref idref="DRAWINGS">FIGS. 7A and 7B</figref> and <figref idref="DRAWINGS">FIGS. 16A to 18B</figref>, a third embodiment of the present disclosure will be described. The same components as those of the above-described embodiment are given the same reference signs, and detailed descriptions thereof will be omitted. In the present embodiment, a nuclear magnetic resonance imaging diagnostic apparatus (MRI) is used to visualize the inside of the body, medical devices, medical-device guide devices, etc.
0120In the present embodiment, an example in which two attachments <b>133</b> and <b>134</b>, respectively illustrated in <figref idref="DRAWINGS">FIGS. 16A and 16B</figref>, are used will be described. The attachments <b>133</b> and <b>134</b> respectively include ring-shaped holding portions <b>133</b><i>a </i>and <b>134</b><i>a</i>. By inserting the apparatus main body <b>1</b> into the holding portions <b>133</b><i>a </i>and <b>134</b><i>a</i>, the apparatus main body <b>1</b> can be fixed to the attachments <b>133</b> and <b>134</b>. The holding portion <b>133</b><i>a </i>is formed parallel to the horizontal plane, and the holding portion <b>134</b><i>a </i>is formed so as to be inclined at a predetermined angle δ with respect to the horizontal plane. That is, the holding portion <b>134</b><i>a </i>is formed so as to be slanted at a predetermined angle δ with respect to the horizontal plane of the attachment <b>134</b>. The holding portions <b>133</b><i>a </i>and <b>134</b><i>a </i>may be formed so that the central axis of each pass through the remote center of motion (RCM) <b>11</b> of the apparatus main body <b>1</b>.
0121In using an MRI modality, an RF coil for amplifying the signals is used to acquire clear images. <figref idref="DRAWINGS">FIG. 16C</figref> is a schematic perspective view of an exemplary single loop coil <b>135</b>, which is a kind of RF coil. The single loop coil <b>135</b> is a kind of surface coil to be placed over the body surface of the object to be imaged. To accommodate the surface coil <b>135</b>, the attachment <b>133</b> includes a notched opening <b>133</b><i>b </i>and the attachment <b>134</b> includes a notched opening <b>134</b><i>b </i>respectively.
0122<figref idref="DRAWINGS">FIGS. 17A and 17B</figref> are schematic perspective views of needle placement manipulators <b>131</b> and <b>132</b> including the attachments <b>133</b> and <b>134</b>, respectively, according to the third embodiment. The configuration of the apparatus main bodies <b>1</b> of the needle placement manipulators <b>131</b> and <b>132</b> are the same as the configuration of the above-described embodiments. In the present embodiment, the attachments <b>133</b> and <b>134</b> are each combined with the apparatus main body <b>1</b> to constitute the needle placement manipulators <b>131</b> and <b>132</b>, respectively.
0123<figref idref="DRAWINGS">FIGS. 18A and 18B</figref> respectively illustrate simulated puncture of the target tissue <b>14</b> using the needle placement manipulators <b>131</b> and <b>132</b> and the attachments <b>133</b> and <b>134</b> placed on the patient's skin <b>15</b>. In using the MRI for visualization, the single loop coil <b>135</b> is first positioned and fixed on the patient's skin <b>15</b> with tape or a belt to acquire a sharp image of the target site. After completion of the fixation of the single loop coil <b>135</b>, the apparatus main body <b>1</b> is fixed on the body of the patient using the attachment <b>133</b>, as illustrated in <figref idref="DRAWINGS">FIG. 18A</figref>. In this case, the remote center of motion (RCM) <b>11</b> of the main body <b>1</b> may be set on the skin <b>15</b>, and the puncture point may not move regardless of displacement of the first and second rotation guides <b>3</b> and <b>4</b>. However, in <figref idref="DRAWINGS">FIG. 18A</figref>, the intended target tissue <b>14</b> is not within coverage, so that the tip of needle <b>12</b> cannot be brought to the target tissue <b>14</b> even if the first and second rotation guides <b>3</b> and <b>4</b> are rotated. In that case, the needle placement manipulator <b>131</b> is removed, and the attachment <b>134</b> is newly placed on the single loop coil <b>135</b> fixed to the skin <b>15</b>. Then, planning for bringing the needle <b>12</b> to the target tissue <b>14</b> is performed on the basis of the posture of the apparatus main body <b>1</b> detected using the markers <b>16</b>, and when it is determined that the target tissue <b>14</b> is within the coverage, the first and second rotation guides <b>3</b> and <b>4</b> are displaced to predetermined positions to direct the needle <b>12</b> to the target tissue <b>14</b>. In the present embodiment, by shifting from the attachment <b>133</b> to the attachment <b>134</b> to change the posture of the apparatus main body <b>1</b>, the target tissue <b>14</b> can fall within the coverage, allowing the needle <b>12</b> to reach the target tissue <b>14</b>, as illustrated in <figref idref="DRAWINGS">FIG. 18B</figref>. The coverage of the needle placement manipulator can be corrected using the attachment <b>134</b> of the present disclosure, as in the first embodiment, under the same principles illustrated in <figref idref="DRAWINGS">FIGS. 10A and 10B</figref>.
0124In the present embodiment, even if it is found that the target tissue <b>14</b> is out of the coverage of the needle placement manipulator <b>131</b> or <b>132</b> after the needle placement manipulator <b>131</b> or <b>132</b> is placed on the body of the patient, the combined use of the attachment <b>133</b> or <b>134</b> and the apparatus main body <b>1</b> allows the coverage to be corrected by replacing the attachment to correct the coverage without removing the RF coil. In other words, the posture of the needle placement manipulator can be changed so that the target tissue <b>14</b> falls within the coverage without removing the RF coil. Changing the posture of the needle placement manipulator using the attachment <b>133</b> or <b>134</b> described in the present embodiment eliminates the need to remove the RF coil from the surface of the body of the patient when change in coverage is needed. This prevents degradation of the quality of the MRI image due to movement of the RF coil and eliminates the need to position the RF coil again, leading to shorter operation time. The present embodiment enables not only to correct the coverage using the attachment <b>133</b> or <b>134</b> so that the target tissue <b>14</b> falls within the coverage but also to change the posture using the attachment <b>133</b> or <b>134</b> to prevent, for example, the interference between the bore and the apparatus main body <b>1</b>.
0125The present embodiment allows the position and posture of the apparatus main body <b>1</b> to be determined without interference with the RF coil without adding significant design changes to the apparatus main body <b>1</b> by preparing attachments matching the apparatus main body <b>1</b> and various RF coils to set the remote center of motion (RCM) to an intended position.
0126The present embodiment also has the effect of preventing the puncture point on the patient's skin set by planning from moving even if the posture is changed by selecting an attachment so that the central axis of the mount portions of the attachment passes through the remote center of motion of the apparatus main body <b>1</b>.
0127In addition, in the present embodiment, the attachment is formed as a single component, so that the attachment can be manufactured at low cost by, for example, injection molding of a resin material. The low-cost manufacture allows the attachment to be a disposal component, which makes it possible to omit preoperative sterilization work etc., contributing to improving surgical quality.
0128Although the present embodiment has been described as related to a needle placement manipulator whose apparatus main body has a remote center of motion (RCM) mechanism, it is to be understood that the apparatus main body has only to include a guide for positioning the insertion axis of the needle and that the apparatus main body may have any configuration.
0129It should also be understood that the workflow for determining whether the target tissue is within the coverage of the apparatus main body is given for mere illustration and that application of the present disclosure is not limited thereto.
0130In the present embodiment, an example in which the coverage is changed by changing the attachment has been described. However, the coverage may be changed using a single attachment, as in the embodiments described below.
0131Although the present embodiment has been described using an MRI as a modality for visualization, the present disclosure is not limited thereto. For example, the present disclosure may easily be applied to the configuration of a computed tomography (CT) scanner.
0132Although the present embodiment has a configuration in which the central axes of the holding portions <b>133</b><i>a </i>and <b>134</b><i>a </i>pass through the remote center of motion (RCM) <b>11</b> of the apparatus main body <b>1</b>, the present disclosure is not limited thereto. The coverage correction range can also be increased without passing the central axes of the holding portions <b>133</b><i>a </i>and <b>134</b><i>a </i>through the remote center of motion (RCM) of the apparatus main body <b>1</b>.
Fourth Embodiment
0133Referring to <figref idref="DRAWINGS">FIGS. 19 to 24</figref>, a fourth embodiment of the present disclosure will be described. The same components as those of the above-described embodiment are given the same reference signs, thus detailed descriptions thereof will be omitted. In the present embodiment, a nuclear magnetic resonance imaging diagnostic apparatus (MRI) is used to visualize the inside of the body, medical devices, medical-device guide devices, etc.
0134In the present embodiment, an example in which a phased array coil <b>145</b> is used as an RF coil for amplifying the signals in order to obtain a clearer image in using MRI will be described. It is known that a phased array coil can improve the signal-to-noise ratio (SNR) of MR images by combining a plurality of small coils to increase the number of channels, as compared with the surface coil described in the third embodiment. <figref idref="DRAWINGS">FIG. 19</figref> is a schematic perspective view of the phased array coil <b>145</b>. The phased array coil <b>145</b> has four openings <b>145</b><i>c</i>, whose edges <b>145</b><i>d </i>are rectangular. The phased array coil <b>145</b> includes processing units <b>145</b><i>a </i>that process RF signals and a cable <b>145</b><i>b </i>for signal transmission and reception. <figref idref="DRAWINGS">FIG. 20</figref> is a schematic perspective view of the phased array coil <b>145</b> illustrating a state in which a needle placement manipulator <b>141</b> is disposed in the opening <b>145</b><i>c</i>. In the present embodiment, an attachment <b>142</b> is combined with the apparatus main body <b>1</b> to constitute the needle placement manipulator <b>141</b> configured or adapted to be attached to the phased array coil <b>145</b>.
0135Referring to <figref idref="DRAWINGS">FIG. 19</figref> and <figref idref="DRAWINGS">FIGS. 21A to 21C</figref>, the details of the attachment <b>142</b> will be described. <figref idref="DRAWINGS">FIGS. 21A and 21B</figref> are schematic perspective views of the attachment <b>142</b>, as viewed from a direction in which the apparatus main body <b>1</b> is attached thereto. <figref idref="DRAWINGS">FIG. 21C</figref> is a schematic perspective view of the attachment <b>142</b>, as viewed from the back (from a direction opposite to the direction in which the apparatus main body <b>1</b> is attached thereto). The attachment <b>142</b> includes a fixed portion <b>143</b> and a movable portion <b>144</b>. As shown in <figref idref="DRAWINGS">FIG. 21C</figref>, the fixed portion <b>143</b> has a protruding portion <b>143</b><i>a </i>extending perpendicularly to a mount surface <b>143</b><i>e</i>. The attachment <b>142</b> can be positioned with respect to the phased array coil <b>145</b> by fitting the protruding portion <b>143</b><i>a </i>to the edge <b>145</b><i>d</i>. An adhesive material (e.g. tape) may be provided on the mount surface <b>143</b><i>e </i>of the fixed portion <b>143</b> so that the mount surface <b>143</b><i>e </i>can be temporarily bonded to a surface <b>145</b><i>e </i>of the phased array coil <b>145</b> during needle placement operation. The movable portion <b>144</b> has an axial fitting portion <b>144</b><i>a </i>(cylindrical fitting portion) and at least one ridge key <b>144</b><i>c</i>. The groove <b>2</b><i>b </i>provided on the bottom of the apparatus main body <b>1</b> is fitted to the ridge key <b>144</b><i>c</i>, and the hole-like (cylindrical) fitting portion <b>2</b><i>a </i>provided in base of the apparatus main body <b>1</b> is fitted to the axial fitting portion <b>144</b><i>a </i>of the movable portion <b>144</b>, so that the apparatus main body <b>1</b> can be mounted to the attachment <b>142</b>.
0136<figref idref="DRAWINGS">FIGS. 22A and 22B</figref> are schematic cross-sectional views of the attachment <b>142</b> taken along a plane <b>146</b> in <figref idref="DRAWINGS">FIG. 21B</figref>. The fixed portion <b>143</b> and the movable portion <b>144</b> respectively include cylindrical surfaces that serve as cylindrical guides <b>143</b><i>b </i>and <b>144</b><i>b</i>. In this manner, the cylindrical surface of movable portion <b>144</b> can slide along the cylindrical guide <b>143</b><i>b </i>of fixed portion <b>143</b>. The center line <b>147</b> of the fixed portion <b>143</b> and the center line <b>148</b> of the movable portion <b>144</b> respectively correspond to central planes of the cylindrical guides <b>143</b><i>b </i>and <b>144</b><i>b</i>. When the cylindrical surface of movable portion <b>144</b> (cylindrical guide <b>144</b><i>b</i>) slides along the cylindrical guide <b>143</b><i>b </i>the center line <b>148</b> can be bidirectionally displaced by a predetermined angle δ with respect to the center line <b>147</b> centering on a central axis <b>149</b>. The posture of the movable portion <b>144</b> may be fixed using a layered piezoelectric element or a knurled knob mechanism, as those described in the previous embodiments.
0137<figref idref="DRAWINGS">FIGS. 23A and 23B</figref> illustrate simulated puncture of the target tissue <b>14</b> using the needle placement manipulator <b>141</b> placed on the patient's skin <b>15</b>. In using an MRI modality for visualization, the phased array coil <b>145</b> is first positioned and fixed on the patient's skin <b>15</b> with a tape or band to acquire a sharp image of a target site. After completion of the fixation of the phased array coil <b>145</b>, the apparatus main body <b>1</b> is fixed on the body of the patient using the attachment <b>142</b>. In a case as shown in <figref idref="DRAWINGS">FIG. 23A</figref>, the target tissue <b>14</b> is not within coverage, so that the tip of needle <b>12</b> cannot be brought to the target tissue <b>14</b> even if the first and second rotation guides <b>3</b> and <b>4</b> are rotated. In that case, for the apparatus main body <b>1</b> and the attachment <b>142</b>, the movable portion <b>144</b> is slid along the cylindrical guide <b>143</b><i>b </i>to the position illustrated in <figref idref="DRAWINGS">FIG. 23B</figref>. Then, planning for bringing the needle <b>12</b> to the target tissue <b>14</b> is performed on the basis of the posture of the apparatus main body <b>1</b> detected using the markers <b>16</b>, and when it is determined that the target tissue <b>14</b> is within the coverage, the first and second rotation guides <b>3</b> and <b>4</b> are displaced to predetermined positions to direct the needle <b>12</b> to the target tissue <b>14</b>. In the present embodiment, by changing the posture of the apparatus main body <b>1</b> using the movable portion <b>144</b> of attachment <b>142</b>, the target tissue <b>14</b> can fall within the coverage, as illustrated in <figref idref="DRAWINGS">FIG. 23B</figref>.
0138<figref idref="DRAWINGS">FIG. 24</figref> illustrates the coverage of the needle placement manipulator <b>141</b> with the attachment <b>142</b> of the present embodiment. In the present embodiment, since the remote center of motion <b>11</b> of the apparatus main body and the central axis <b>149</b> of the cylindrical guide <b>144</b><i>b </i>are offset, the remote center of motion <b>11</b> moves along an arcuate path <b>150</b> (cylindrical locus) as the movable portion <b>144</b> moves two-directionally with respect to the fixed portion <b>143</b>. Therefore, the conical coverage <b>108</b> also moves bidirectionally by an angle δ as the remote center of motion <b>11</b> moves. That is, the conical coverage <b>108</b> can be adjusted along a curved locus (arcuate path <b>150</b>).
0139In the present embodiment, even if it is found that the target tissue <b>14</b> is out of coverage of the needle placement manipulator <b>141</b> after the needle placement manipulator <b>141</b> is placed on the body of the patient, the combined use of the attachment <b>142</b> and the apparatus main body <b>1</b> allows the coverage to be corrected without removing the RF coil by sliding the movable portion <b>144</b> of the attachment <b>142</b> along the cylindrical guide <b>143</b><i>b</i>. In other words, the posture of the needle placement manipulator <b>141</b> can be changed so that the target tissue <b>14</b> falls within the coverage. Changing the posture of the needle placement manipulator <b>141</b> using the attachment <b>142</b> described in the present embodiment eliminates the need to remove the RF coil from the surface of the body of the patient when change in coverage is needed. This prevents degradation of the quality of the MRI image due to movement of the RF coil and eliminates the need to position the RF coil again, leading to shorter operation time. The present embodiment enables not only to correct the coverage using the attachment <b>142</b> so that the target tissue <b>14</b> falls within the coverage but also to change the posture using the attachment <b>142</b> to prevent, for example, the interference between the bore of the imaging modality and the apparatus main body <b>1</b>. In addition, the present embodiment can enable positioning the needle <b>12</b> to the same target tissue <b>14</b> from different directions which is effective in multiple-needle puncture planning.
0140In the present embodiment, the amount of movement of the coverage can be increased as compared with the above-described embodiments by offsetting (moving) the central axis <b>149</b> with respect to the remote center of motion <b>11</b>. The present embodiment allows the position and posture of the apparatus main body <b>1</b> to be determined without interference with the RF coil without adding significant design changes to the apparatus main body <b>1</b> by preparing attachments matching the apparatus main body <b>1</b> and various RF coils to set the remote center of motion (RCM) to an intended position.
0141Although the present embodiment has been described as related to a needle placement manipulator whose apparatus main body has a remote center of motion (RCM) mechanism, it is to be understood that the apparatus main body has only to include a guide for positioning the insertion axis of the needle and that the apparatus main body may have any configuration. It should also be understood that the workflow for determining whether the target tissue is within the coverage of the apparatus main body is given for mere illustration and that application of the present disclosure is not limited thereto.
0142Although the present embodiment has been described using an MRI as a modality for visualization, the present disclosure is not limited thereto. For example, the present embodiment may easily be applied to the configuration of a computed tomography (CT) scanner or an ultrasound imaging modality.
0143Although the present embodiment is an example configuration in which the remote center of motion (RCM) <b>11</b> of the apparatus main body <b>1</b> does not come to the central axis of the guide, the present disclosure is not limited to the configuration. An attachment similar to those of the other embodiments may be used so that the remote center of motion (RCM) of the apparatus main body <b>1</b> is disposed on the central axis of the cylindrical guide. Although a method for changing the posture of the movable portion using a cylindrical guide has been described, a spherical guide may be used as in the above-described embodiments. Notably, in the case of using spherical guides (instead of cylindrical guides), the coverage of the needle placement manipulator <b>141</b> using the attachment <b>142</b> can be increased omni-directionally by an angle δ as the conical coverage <b>108</b> could move more than 360 degrees around the conical coverage <b>108</b> while being centered on the central axis <b>149</b>.
Fifth Embodiment
0144Referring to <figref idref="DRAWINGS">FIGS. 25 to 30</figref>, a fifth embodiment of the present disclosure will be described. The same components as those of the above-described embodiments are given the same reference signs, and detailed descriptions thereof will be omitted. In the present embodiment, an X-ray computed tomography (CT) scanner is used to visualize the inside of the body, medical devices, medical-device guide devices, etc.
0145<figref idref="DRAWINGS">FIG. 25</figref> is a schematic perspective view of a needle placement manipulator <b>151</b> of a fifth embodiment of the present disclosure. The configuration of the apparatus main body <b>1</b> of the needle placement manipulator <b>151</b> is the same as the configuration of the above-described embodiments. In the present embodiment, an attachment <b>152</b> is combined with the apparatus main body <b>1</b> to constitute the needle placement manipulator <b>151</b>. <figref idref="DRAWINGS">FIGS. 26A and 26B</figref> are schematic perspective views of the attachment <b>152</b> as viewed from two different sides (top and bottom views). The attachment <b>152</b> includes three components, a fixed portion <b>153</b>, a first movable portion <b>154</b>, and a second movable portion <b>155</b>. The second movable portion <b>155</b> includes a ridge key <b>155</b><i>b </i>on the top surface thereof. As in the above-described embodiments, the groove <b>2</b><i>b </i>provided on the bottom of the apparatus main body <b>1</b> is fitted to the ridge key <b>155</b><i>b </i>so that the apparatus main body <b>1</b> can be mounted and fixed to a predetermined position. The bottom of the fixed portion <b>153</b> has a curved mounting surface <b>153</b><i>a </i>with smooth spherical shape to keep a stable mount condition by conforming to the contour shape of a patient's body.
0146Next, referring to <figref idref="DRAWINGS">FIG. 27A</figref> to <figref idref="DRAWINGS">FIG. 30</figref>, the structure of attachment <b>152</b> and the functions of the first movable portion <b>154</b> and the second movable portion <b>155</b> will be described in detail. The axes of coordinates are common among the drawings. <figref idref="DRAWINGS">FIGS. 27A and 27B</figref> schematically illustrate a state of puncturing the target tissue <b>14</b> using the needle placement manipulator <b>151</b> placed on the patient's skin <b>15</b>, in which the human skin <b>15</b> is approximately treated as a spherical surface having a radius R centered on a point <b>159</b>. <figref idref="DRAWINGS">FIG. 28A</figref> is a schematic perspective view of the attachment <b>152</b>, and <figref idref="DRAWINGS">FIG. 28B</figref> is a schematic plan view of the attachment <b>152</b> (observed in the direction in which the apparatus main body <b>1</b> is attached thereto).
0147In the drawings, the contact portion between the fixed portion <b>153</b> and the first movable portion <b>154</b> is provided with a guide <b>153</b><i>b </i>having a spherical shape centered on the point <b>159</b> and slidable about a spherical surface having an axis passing through the point <b>159</b> and parallel to the z-axis. The guide <b>153</b><i>b </i>is on a spherical surface having a radius (R+t), where t is the distance between the patient's surface skin <b>15</b> and the guide <b>153</b><i>b</i>. In the drawings, the contact portion between the first movable portion <b>154</b> and the second movable portion <b>155</b> is provided with a guide <b>154</b><i>b </i>having a spherical shape centered on the center <b>159</b> and slidable about a spherical surface having an axis passing through the center <b>159</b> and parallel to the z-axis. The guide <b>154</b><i>b </i>is on a spherical surface having a radius of (R+t+s), where s is the distance between the first guide <b>153</b><i>b </i>and the second guide <b>154</b><i>b. </i>
0148In <figref idref="DRAWINGS">FIGS. 27A and 27B</figref>, the remote center of motion (RCM) <b>11</b> of the apparatus main body <b>1</b> may be set on the skin <b>15</b> by setting (t+s) to an appropriate size. <figref idref="DRAWINGS">FIG. 27A</figref> illustrates a state in which the target tissue <b>14</b> is out of coverage, so that the tip of needle <b>12</b> cannot be brought to the target tissue <b>14</b> even if the first and second rotation guides <b>3</b> and <b>4</b> are rotated. However, the target tissue <b>14</b> can be put in the coverage by changing the posture of the first movable portion <b>154</b> using the attachment <b>152</b> of the present disclosure, allowing the needle <b>12</b> to reach the target tissue <b>14</b>, as illustrated in <figref idref="DRAWINGS">FIG. 27B</figref>. A method for determining whether the target tissue <b>14</b> is within the coverage of the apparatus main body <b>1</b> is the same as the method of the first embodiment, and a detailed description thereof will be omitted. The first movable portion <b>154</b> and the second movable portion <b>155</b> can be moved manually or with any actuator, as described in the above embodiments. This also applies to fixation.
0149The coverage of the needle placement manipulator <b>151</b> of the present embodiment will be described. <figref idref="DRAWINGS">FIG. 29A</figref> is a diagram illustrating the effect of coverage expansion due to the movement of the first movable portion <b>154</b>. In the drawing of <figref idref="DRAWINGS">FIG. 29A</figref>, the guide <b>153</b><i>b </i>slides bidirectionally by an angle ±4 on a spherical plane (spherical locus) <b>160</b> with a radius (R+t) centered on the point <b>159</b>. As the remote center of motion <b>11</b> slides along an arcuate path in a range <b>156</b> on the skin <b>15</b>, the conical coverage <b>108</b> with the remote center of motion <b>11</b> as a vertex and with an apical angle 4θ also moves along the arcuate path. <figref idref="DRAWINGS">FIG. 29B</figref> is a diagram illustrating the effect of coverage expansion due to the movement of the second movable portion <b>155</b>. In the drawing, the guide <b>154</b><i>b </i>slides bidirectionally by an angle ±φ on a spherical plane (spherical locus) <b>165</b> with a radius of (R+t+s) centered on the point <b>159</b>. Accordingly, as the remote center of motion <b>11</b> moves in a range <b>157</b> on the skin <b>15</b>, the conical coverage <b>108</b> with the remote center of motion <b>11</b> as the vertex and with an apical angle 4θ also moves along an arcuate path with range <b>157</b>. <figref idref="DRAWINGS">FIG. 30</figref> illustrates the moving range of the conical coverage <b>108</b> based on the combined ranges described above. Since the first and second movable portions <b>154</b> and <b>155</b> respectively move along spherical loci <b>160</b> and <b>165</b> that are perpendicular to each other, the coverage <b>108</b> can be moved to any position within the region enclosed by a line <b>158</b> as the remote center of motion <b>11</b> slides in the ranges <b>156</b> and <b>157</b> on the skin <b>15</b>.
0150In the present embodiment, even if it is found that the target tissue <b>14</b> is out of coverage of the needle placement manipulator <b>151</b> after the needle placement manipulator <b>151</b> is secured onto the body of the patient, the combined use of the attachment <b>152</b> and the apparatus main body <b>1</b> allows the coverage to be corrected by sliding the first and/or second movable portions <b>154</b> and <b>155</b> to change the posture of the apparatus main body <b>1</b>. In other words, the posture of the needle placement manipulator <b>151</b> can be changed so that the target tissue <b>14</b> falls within the coverage. Since the remote center of motion <b>11</b> of the apparatus main body <b>1</b> can be moved to a position in the range <b>158</b> on the spherical plane, the coverage expansion range is larger than those in the previous embodiments. Changing the posture of the needle placement manipulator <b>151</b> using the attachment <b>152</b> described in the present embodiment eliminates the need to remove the attachment <b>152</b> and the needle placement manipulator <b>151</b> from the surface of the body of the patient when change in coverage is needed. This allows the sterilized state of the attachment <b>152</b> and the needle placement manipulator <b>151</b> to be kept, leading to improvement of the safety of surgery. The present embodiment enables not only to correct the coverage using the attachment <b>152</b> so that the target tissue <b>14</b> falls within the coverage but also to change the posture using the attachment <b>152</b> to prevent, for example, the interference between the bore of the imaging modality and the apparatus main body <b>1</b>.
0151The present embodiment also has the effect of preventing the puncture point on the patient's skin set by planning from moving even if the posture is changed using the attachment by forming the guide of the attachment so that the remote center of motion <b>11</b> of the apparatus main body <b>1</b> moves on the skin <b>15</b>. Moreover, present embodiment can have the effect of allowing the performance of more than one puncture operation within the range <b>158</b> without having to remove and reattach the manipulator.
0152Although the present disclosure has been described as related to a needle placement manipulator whose apparatus main body has the remote center of motion (RCM) mechanism, it is to be understood that the apparatus main body need only include a guide for positioning the needle insertion axis and that the apparatus main body may have any configuration.
0153It should also be understood that the workflow for determining whether the target tissue is within the coverage of the apparatus main body is given for mere illustration and that application of the present disclosure is not limited thereto.
0154Although the present embodiment has been described as applied to a configuration in which a piezoelectric actuator is used as the driving unit, and an optical encoder is used as the detecting unit, it is to be understood that the present disclosure is not limited thereto. Any other actuator and any other sensor may be respectively used as the driving unit and the detecting unit. The rotational displacement of the first and second rotation guides may be manually adjusted without using an actuator and a sensor.
0155In the present embodiment, the patient's skin <b>15</b> is approximated to a spherical plane, and the guides <b>153</b><i>b </i>and <b>154</b><i>b </i>are described as a spherical surface having the same center as the sphere of the skin <b>15</b>. However, the present disclosure is not limited to the configuration. For example, the centers of the spheres that the skin <b>15</b>, the guide <b>153</b><i>b</i>, and the guide <b>154</b><i>b </i>form may differ or the radii of the spheres may differ. Instead of the spherical guides, a guide having any curved shape that matches the specific shape of the patient's body may be produced to allow the needle placement manipulator to be more precisely placed. In addition, a cylindrical guide or a straight (planar) guide may be used instead of the spherical guides, which may reduce manufacturing costs.
0156In the present embodiment, the attachment includes two movable portions. However, the attachment may have one movable portion having a movable range of two degrees of freedom. A configuration that allows posture change with multiple degrees of freedom is also possible by using three or more movable portions.
0157Although the present embodiment has been described using a CT scanner as a modality for visualization, the present disclosure is not limited thereto. For example, the present disclosure may be applied to the configuration of a nuclear magnetic resonance imaging (MRI) diagnostic apparatus. In this case, non-magnetic metal, resin, or ceramic may be used as a material of the needle placement manipulator and the attachment. In that case, a material of the markers may be a substance containing hydrogen atoms, such as an aqueous copper sulfate solution. In using the MRI, an RF coil for transmitting and receiving signals may be disposed below or in the vicinity of the attachment, as will be illustrated in the embodiments described below.
Sixth Embodiment
0158Referring to <figref idref="DRAWINGS">FIGS. 31A to 34D</figref>, a sixth embodiment of the present disclosure will be described. The same components as those of the above-described embodiment are given the same reference signs, and detailed descriptions thereof will be omitted. In the present embodiment, a nuclear magnetic resonance imaging diagnostic apparatus (MRI) is used to visualize the inside of the body, medical devices, medical-device guide devices, etc.
0159In the present embodiment, an example in which a phased array coil <b>145</b> is used as an RF coil in order to obtain a clearer image in using an MRI modality will be described. <figref idref="DRAWINGS">FIG. 31A</figref> is a schematic perspective view of a needle placement manipulator <b>161</b> disposed in an opening <b>145</b><i>c </i>of the phased array coil <b>145</b>. In the present embodiment, an attachment <b>162</b> is combined with the apparatus main body <b>1</b> to constitute the needle placement manipulator <b>161</b>.
0160Referring to <figref idref="DRAWINGS">FIGS. 31A to 33D</figref>, the details of the attachment <b>162</b> will be described. <figref idref="DRAWINGS">FIG. 32A</figref> is a schematic perspective view of the attachment <b>162</b>, and <figref idref="DRAWINGS">FIG. 32B</figref> is a schematic perspective view of the attachment <b>162</b> as viewed from the back. <figref idref="DRAWINGS">FIGS. 32C and 32D</figref> are respective enlarged views of dashed-line regions E and F in <figref idref="DRAWINGS">FIG. 32A</figref>. The attachment <b>162</b> includes a fixed portion <b>163</b> and a movable portion <b>164</b>. The fixed portion <b>163</b> has a recessed portion <b>163</b><i>d </i>on the back, so that the attachment <b>162</b> can be positioned and fixed to the phased array coil <b>145</b> by fitting the recessed portion <b>163</b><i>d </i>to the edge <b>145</b><i>d. </i>
0161<figref idref="DRAWINGS">FIG. 33A</figref> is a schematic perspective view of the movable portion <b>164</b>. The movable portion <b>164</b> has a ridge key <b>164</b><i>b</i>. The groove <b>2</b><i>b </i>provided on the bottom of the apparatus main body <b>1</b> is fitted to the ridge key <b>164</b><i>b</i>, so that the position and posture of the apparatus main body <b>1</b> relative to the attachment <b>162</b> can be fixed. As illustrated in <figref idref="DRAWINGS">FIG. 33B</figref>, the movable portion <b>164</b> has an internal thread <b>164</b><i>a </i>at one end, to which an external thread <b>116</b><i>a </i>of a knurled knob <b>116</b> can be attached. The movable portion <b>164</b> has a columnar slider <b>164</b><i>c </i>(in the shape of a cylindrical pin) at the other end. The needle placement manipulator <b>161</b> is configured such that the attachment <b>162</b> is formed so that the remote center of motion (RCM) <b>11</b> of the apparatus main body <b>1</b> is on a straight line connecting the center of the internal thread <b>164</b><i>a </i>and the center of the slider <b>164</b><i>c</i>. Referring to <figref idref="DRAWINGS">FIGS. 32C and 32D</figref>, the fixed portion <b>163</b> has a clearance <b>163</b><i>a </i>for sliding the movable portion <b>164</b>, a clearance <b>163</b><i>b </i>for sliding the knurled knob <b>116</b>, and a rail <b>163</b><i>c </i>for guiding the slider <b>164</b><i>c</i>. Thus, the attachment <b>162</b> has a mechanism in which the movable portion <b>164</b> can slide along the rail <b>163</b><i>c </i>and can rotate (pivot) about the straight line connecting the center of the internal thread <b>164</b><i>a </i>and the center of the slider <b>164</b><i>c </i>with two degrees of freedom; see “slide” and “pivot” arrows in <figref idref="DRAWINGS">FIGS. 32C and 32D</figref>, respectively. Therefore, the attachment <b>162</b> can change the position and posture of the apparatus main body <b>1</b> while the remote center of motion (RCM) <b>11</b> of the apparatus main body <b>1</b> is kept on the skin <b>15</b> or keeps the distance from the skin <b>15</b> constant by loosening the external thread <b>116</b><i>a </i>and the internal thread <b>164</b><i>a</i>, and can keep the position and posture by tightening the knurled knob <b>116</b> to lock the movable portion <b>164</b> at a desired position and posture.
0162<figref idref="DRAWINGS">FIGS. 34A to 34D</figref> illustrate simulated puncture of the target tissue <b>14</b> using the needle placement manipulator <b>161</b> placed on the patient's skin <b>15</b>. In using the MRI modality for visualization, the phased array coil <b>145</b> is first positioned and fixed on the patient's skin <b>15</b> with a tape or band to acquire a sharp image of the target site. After completion of the fixation of the phased array coil <b>145</b>, the apparatus main body <b>1</b> is fixed on the body of the patient using the attachment <b>162</b>. In <figref idref="DRAWINGS">FIG. 34A</figref>, the target tissue <b>14</b> is not within coverage, so that the tip of needle <b>12</b> cannot be brought to the target tissue <b>14</b> even if the first and second rotation guides <b>3</b> and <b>4</b> are rotated. In that case, for the apparatus main body <b>1</b> and the attachment <b>162</b>, the movable portion <b>164</b> is rotated (pivoted) about the central axis of the slider <b>164</b><i>c</i>, as illustrated in <figref idref="DRAWINGS">FIG. 34B</figref>. Then, planning for bringing the needle <b>12</b> to the target tissue <b>14</b> is performed on the basis of the posture of the apparatus main body <b>1</b> detected using the markers <b>16</b>, and when it is determined that the target tissue <b>14</b> is within the coverage, the first and second rotation guides <b>3</b> and <b>4</b> are displaced to predetermined positions to direct the needle <b>12</b> to the target tissue <b>14</b>. In the present embodiment, the coverage can be further expanded by sliding the movable portion <b>164</b> rightwards in the plane of the drawing along the rail <b>163</b><i>c</i>, as illustrated in <figref idref="DRAWINGS">FIGS. 34C and 34D</figref>. For example, by sliding the movable portion <b>164</b> along the rail <b>163</b><i>c </i>while keeping the posture illustrated in <figref idref="DRAWINGS">FIG. 34B</figref>, a new target tissue <b>14</b> can be put in the coverage, as illustrated in <figref idref="DRAWINGS">FIG. 34C</figref>. Furthermore, for example, by sliding the movable portion <b>164</b> along the rail <b>163</b><i>c </i>while keeping the posture illustrated in <figref idref="DRAWINGS">FIG. 34B</figref>, the target tissue <b>14</b> at the same position as in the <figref idref="DRAWINGS">FIG. 34B</figref>, as illustrated in <figref idref="DRAWINGS">FIG. 34D</figref>, can be positioned from different directions by rotating the first and second rotation guides <b>3</b> and <b>4</b>.
0163In the present embodiment, by changing the posture of the apparatus main body <b>1</b> using the attachment <b>162</b>, the target tissue <b>14</b> can fall within the coverage, and the needle <b>12</b> can be brought to the target issue <b>14</b>, as illustrated in <figref idref="DRAWINGS">FIGS. 34B, 34C, and 34D</figref>. Furthermore, by increasing the degree of freedom of the movable portion <b>164</b>, positioning to the target tissue <b>14</b> from different directions can be performed. This allows planning for the target tissue <b>14</b> excluding human tissue, such as bones, which should not be hurt by the needle <b>12</b>, if included in the puncture path. In addition, positioning the needle <b>12</b> to the same target tissue <b>14</b> from different directions is also effective in multiple-needle puncture therapy for expanding a frozen region (ice ball) at the leading end of the needle <b>12</b> in freezing therapy or the like. In addition, the ability of positioning a needle to the same target tissue <b>14</b> from different directions can be effective in performing simultaneous percutaneous incisions with multiple needles.
0164In the present embodiment, therefore, even if it is found that the target tissue <b>14</b> is out of the coverage of the needle placement manipulator <b>161</b> after the needle placement manipulator <b>161</b> is placed on the body of the patient, the combined use of the attachment <b>162</b> and the apparatus main body <b>1</b> allows the coverage to be corrected without removing the RF coil by sliding or rotating the movable portion <b>164</b> of the attachment <b>162</b>. In other words, the posture of the needle placement manipulator <b>161</b> can be changed so that the target tissue <b>14</b> falls within the coverage. Changing the posture of the needle placement manipulator <b>161</b> using the attachment <b>162</b> described in the present embodiment eliminates the need to remove the RF coil from the surface of the body of the patient when change in coverage is needed. This prevents degradation of the quality of the MRI image due to movement of the RF coil and eliminates the need to position the RF coil again, leading to shorter operation time. The present embodiment enables not only to correct the coverage using the attachment <b>162</b> so that the target tissue <b>14</b> falls within the coverage but also to change the posture using the attachment <b>162</b> to prevent, for example, the interference between the bore and the apparatus main body <b>1</b>.
0165The present embodiment allows the position and posture of the apparatus main body <b>1</b> to be determined without interference with the RF coil without adding significant design changes to the apparatus main body <b>1</b> by preparing attachments matching the apparatus main body <b>1</b> and various RF coils to set the remote center of motion (RCM) to an intended position.
0166Although the present embodiment has been described as related to a needle placement manipulator whose apparatus main body has a remote center of motion (RCM) mechanism, it is to be understood that the apparatus main body has only to include a guide for positioning the insertion axis of the needle and that the apparatus main body may have any configuration.
0167It should also be understood that the workflow for determining whether the target tissue is within the coverage of the apparatus main body is given for mere illustration and that application of the present disclosure is not limited thereto.
0168Although the present embodiment has been described using an MRI as a modality for visualization, the present disclosure is not limited thereto. For example, the present discloser may easily be applied to the configuration of a computed tomography (CT) scanner.
0169In the present embodiment, the position and posture of the apparatus main body <b>1</b> can be changed while the remote center of motion (RCM) <b>11</b> of the apparatus main body <b>1</b> is kept on the skin <b>15</b> or keeps the distance from the skin <b>15</b> constant. However, the present disclosure is not limited to the configuration. It is also easy to configure so that the remote center of motion (RCM) <b>11</b> of the apparatus main body <b>1</b> does not come to the straight line connecting the center of the internal thread <b>164</b><i>a </i>and the center of the slider <b>164</b><i>c</i>, which is also within the scope of the present disclosure.
Seventh Embodiment
0170Referring to <figref idref="DRAWINGS">FIGS. 35A to 40B</figref>, a seventh embodiment of the present disclosure will be described. The same components as those of the above-described embodiment are given the same reference signs, and detailed descriptions thereof will be omitted. In the present embodiment, a nuclear magnetic resonance imaging diagnostic apparatus (MRI) is used to visualize the inside of the body, medical devices, medical-device guide devices, etc.
0171In the present embodiment, an example in which a phased array coil <b>145</b> is used as an RF coil in order to obtain a clearer image in using MRI, as in the fourth and sixth embodiments, will be described. <figref idref="DRAWINGS">FIG. 35A</figref> is a schematic perspective view of a needle placement manipulator <b>171</b> disposed in an opening <b>145</b><i>c </i>of the phased array coil <b>145</b>. In the present embodiment, an attachment <b>172</b> is combined with the apparatus main body <b>1</b> to constitute the needle placement manipulator <b>171</b>.
0172Referring to <figref idref="DRAWINGS">FIGS. 35A to 37B</figref>, the details of the attachment <b>172</b> will be described. <figref idref="DRAWINGS">FIGS. 36A and 36B</figref> are schematic perspective views of the attachment <b>172</b>, and <figref idref="DRAWINGS">FIG. 36C</figref> is a schematic perspective view of the attachment <b>172</b> as viewed from the back. The attachment <b>172</b> includes a fixed portion <b>173</b> and a movable portion <b>174</b>. The fixed portion <b>173</b> has a polygonal opening and a protruding portion <b>173</b><i>a </i>perpendicular to a mount surface <b>173</b><i>e</i>. The attachment <b>172</b> can be positioned and fixed to the phased array coil <b>145</b> by fitting the protruding portion <b>173</b><i>a </i>to the edge <b>145</b><i>d </i>of an opening <b>145</b><i>a </i>of the phased array coil <b>145</b>. An adhesive binding material (e.g., tape) may be provided on the mount surface <b>173</b><i>e </i>so that the mount surface <b>173</b><i>e </i>can be temporality bonded to the surface <b>145</b><i>e </i>of the phased array coil <b>145</b>. The movable portion <b>174</b> has an axial opening <b>174</b><i>a </i>(cylindrical opening) and a ridge key <b>174</b><i>b</i>. The groove <b>2</b><i>b </i>provided on the bottom of the base body <b>2</b> of the apparatus main body <b>1</b> is fitted to the ridge key <b>174</b><i>b</i>, and the hole-like (cylindrical) fitting portion <b>2</b><i>a </i>provided in the apparatus main body <b>1</b> is fit to an axial fitting portion <b>174</b><i>a </i>provided in the attachment <b>172</b>, so that the position and posture of the apparatus main body <b>1</b> relative to the attachment <b>172</b> can be fixed.
0173<figref idref="DRAWINGS">FIGS. 37A and 37B</figref> are schematic perspective views of the movable portion <b>174</b>, and <figref idref="DRAWINGS">FIG. 38</figref> is a schematic perspective view of the fixed portion <b>173</b>. As illustrated in <figref idref="DRAWINGS">FIG. 37B</figref> and <figref idref="DRAWINGS">FIG. 38</figref>, linear guides <b>174</b><i>c </i>and <b>173</b><i>c </i>are respectively provided on the back of the movable portion <b>174</b> and on the upper surface of the fixed portion <b>173</b>. The movable portion <b>174</b> can be linearly moved along the linear guide <b>173</b><i>c</i>, as illustrated in <figref idref="DRAWINGS">FIG. 36B</figref>. In the needle placement manipulator <b>171</b>, the attachment <b>172</b> is configured such that, when the movable portion <b>174</b> is moved along the linear guide <b>173</b><i>c</i>, the remote center of motion (RCM) <b>11</b> of the apparatus main body <b>1</b> is kept on the skin <b>15</b> or keeps the distance from the skin <b>15</b> constant. The movable portion <b>174</b> may be moved manually or using an automated actuator. A fixing unit for fixing (locking) the position of the movable portion <b>174</b> with respect to the fixed portion <b>173</b> may be provided as appropriate. Applicable examples of a fixing unit include the above-described thread with a knurled knob, and the layered piezoelectric element with a compression coil spring, described in the first embodiment. However, locking can be implemented various other ways, including a sliding key, turn lock, or set screw.
0174<figref idref="DRAWINGS">FIGS. 39A and 39B</figref> illustrate simulated puncture to the target tissue <b>14</b> using the needle placement manipulator <b>171</b> disposed on a patient's skin <b>15</b>. <figref idref="DRAWINGS">FIGS. 40A and 40B</figref> are schematic plan views of the needle placement manipulator <b>171</b> disposed on the phased array coil <b>145</b> viewed from directly above. <figref idref="DRAWINGS">FIG. 40B</figref> illustrates a state in which the movable portion <b>174</b> is slid linearly upward in the plane of the drawing from the position in <figref idref="DRAWINGS">FIG. 40A</figref>. <figref idref="DRAWINGS">FIGS. 39A and 39B</figref> are respective schematic cross-sectional views of <figref idref="DRAWINGS">FIGS. 40A and 40B</figref> taken along a plane passing through the needle <b>12</b>.
0175In using the MRI for visualization, the phased array coil <b>145</b> is first positioned and fixed on the patient's skin <b>15</b> with tape or band to acquire a sharp image of the target site. After completion of the fixation of the phased array coil <b>145</b>, the apparatus main body <b>1</b> is fixed on the body of the patient using the attachment <b>172</b>. In <figref idref="DRAWINGS">FIG. 39A</figref>, the target tissue <b>14</b> is not within coverage, so that the tip of needle <b>12</b> cannot be brought to the target tissue <b>14</b> even if the first and second rotation guides <b>3</b> and <b>4</b> are rotated. In that case, for the apparatus main body <b>1</b> and the attachment <b>172</b>, the movable portion <b>174</b> is linearly slid in an upward direction, as illustrated in <figref idref="DRAWINGS">FIG. 40B</figref>. Then, planning for bringing the needle <b>12</b> to the target tissue <b>14</b> is performed on the basis of the posture of the apparatus main body <b>1</b> detected using the markers <b>16</b>, and when it is determined that the target tissue <b>14</b> is within the coverage, the first and second rotation guides <b>3</b> and <b>4</b> are displaced to predetermined positions to position the needle <b>12</b> toward the target tissue <b>14</b>.
0176In the present embodiment, the target tissue <b>14</b> can be brought within the coverage by changing the position of the apparatus main body <b>1</b> along the linear guides <b>173</b><i>c </i>and <b>174</b><i>c </i>using the attachment <b>172</b>, allowing the needle <b>12</b> to be brought to the target tissue <b>14</b>, as illustrated in <figref idref="DRAWINGS">FIG. 39B</figref>. Even if the target tissue <b>14</b> is within the coverage of the needle placement manipulator <b>171</b> in the state of <figref idref="DRAWINGS">FIG. 39A</figref>, the configuration of the present embodiment allows planning for the target tissue <b>14</b> excluding human tissue, such as bones, which should not be hurt by the needle <b>12</b>, if included in the puncture path. In addition, positioning the needle <b>12</b> to the same target tissue <b>14</b> from different directions is also effective in multiple-needle puncture therapy for expanding a frozen region (ice ball) at the leading end of the needle <b>12</b> in freezing therapy or the like.
0177In the present embodiment, even if it is found that the target tissue <b>14</b> is out of the coverage of the needle placement manipulator <b>171</b> after the needle placement manipulator <b>171</b> is placed on the body of the patient, the combined use of the attachment <b>172</b> and the apparatus main body <b>1</b> allows the coverage to be corrected without removing the RF coil by sliding the movable portion <b>174</b> of the attachment <b>172</b> along the linear guide <b>173</b><i>c</i>. In other words, the posture of the needle placement manipulator <b>171</b> can be changed so that the target tissue <b>14</b> falls within the coverage. Changing the posture of the needle placement manipulator <b>171</b> using the attachment <b>172</b> described in the present embodiment eliminates the need to remove the RF coil from the surface of the body of the patient when change in coverage is needed. This prevents degradation of the quality of the MRI image due to movement of the RF coil and eliminates the need to position the RF coil again, leading to shorter operation time. The present embodiment enables not only to correct the coverage using the attachment <b>172</b> so that the target tissue <b>14</b> falls within the coverage but also to change the posture using the attachment <b>172</b> to prevent, for example, the interference between the bore and the apparatus main body <b>1</b>.
0178The present embodiment allows the position and posture of the apparatus main body <b>1</b> to be determined without interference with the RF coil without adding significant design changes to the apparatus main body <b>1</b> by preparing attachments matching the apparatus main body <b>1</b> and various RF coils to set the remote center of motion (RCM) to an intended position.
0179Although the present embodiment has been described as related to a needle placement manipulator whose apparatus main body has a remote center of motion (RCM) mechanism, it is to be understood that the apparatus main body has only to include a guide for positioning the insertion axis of the needle and that the apparatus main body may have any configuration.
0180It should also be understood that the workflow for determining whether the target tissue is within the coverage of the apparatus main body is given for mere illustration and that application of the present disclosure is not limited thereto.
0181Although the present embodiment has been described using an MRI as a modality for visualization, the present disclosure is not limited thereto. For example, the present discloser may easily be applied to the configuration of a computed tomography (CT) scanner.
0182In the present embodiment, the position and posture of the apparatus main body <b>1</b> can be changed while the remote center of motion (RCM) <b>11</b> of the apparatus main body <b>1</b> is kept on the skin <b>15</b> or keeps the distance from the skin <b>15</b> constant. However, the present disclosure is not limited to the configuration.
Eighth Embodiment
0183Instead of having a separate fixed portion and movable portion, the attachment can be implemented as a statically inclined adapter having a predetermined inclination. <figref idref="DRAWINGS">FIGS. 41A to 46</figref> illustrate an eighth embodiment of the present disclosure. The same components as those of the above-described embodiment are given the same reference signs, and detailed descriptions thereof will be omitted. In the present embodiment, a nuclear magnetic resonance imaging (MRI) modality is used to visualize the inside of a patient's body, medical devices, medical-device guide devices, etc. The type of attachment implemented as a statically inclined adapter having a predetermined inclination can be used in scenarios where a specific angulation is often needed. For example, to reach a shallow target tissue which is obstructed from above, to prevent the manipulator from colliding with other medical equipment placed near the manipulator, or to revert the orientation of the manipulator to a perpendicular position if it cannot be mounted directly onto the patient in such position. This statically inclined adapter can be designed in a way where one or more statically inclined adapters can be stacked to achieve additional angulations. For example, the user can place an attachment having a predefined 30 degree inclination, and then, if necessary, place a +5 degrees or −5 degree wedge on top to get to a 25 or 35 degree inclination if the original 30 degrees is not sufficient to reach a target.
0184A statically inclined adapter can be rotated from its original position to adjust the location of the remote center of motion without changing the device footprint. Specifically, in the previously described embodiments, changing the orientation of the apparatus main body <b>1</b> with respect to the target tissue <b>14</b> is achieved by using one or more guides to slide the movable portion with respect to the fixed portion. This mechanical movement changes the overall needle manipulator's footprint. In contrast, by using an attachment having statically inclined surface, the devices' footprint does not change. The rotation can be achieved by rotating the entire assembly; that is, by rotating the attachment and the manipulator together, or by having the statically inclined adapter rotate within the base body <b>2</b> of the apparatus main body <b>1</b>, either manually or electronically.
0185<figref idref="DRAWINGS">FIGS. 41A, 41B and 41C</figref> show a first example of an attachment <b>183</b> designed as a statically inclined adapter. <figref idref="DRAWINGS">FIGS. 42A-42E</figref> show a second example of an attachment <b>283</b> designed as a statically inclined adapter. <figref idref="DRAWINGS">FIGS. 43, 44A, 44B, 44C</figref>, and <b>45</b> illustrate functionality and exemplary applications of the attachments <b>183</b>/<b>283</b> designed as a wedge-shaped adapter for use in a needle placement manipulator. <figref idref="DRAWINGS">FIG. 41A</figref> is a perspective view and <figref idref="DRAWINGS">FIG. 41B</figref> is a top view of the attachment <b>183</b> showing a cylindrical opening <b>183</b><i>a</i>, a ridge key <b>183</b><i>b</i>, and an inclined surface <b>183</b><i>c</i>. <figref idref="DRAWINGS">FIG. 41C</figref> is a bottom view of the attachment <b>183</b> showing a protruding portion <b>183</b><i>d </i>and a mount surface <b>183</b><i>e</i>. The protruding portion <b>183</b><i>d </i>on the bottom of attachment <b>183</b> is configured so that the attachment <b>183</b> can be positioned and fixed to the phased array coil <b>145</b> (see <figref idref="DRAWINGS">FIG. 19</figref>) by fitting the protruding portion <b>183</b><i>d </i>to the edge <b>145</b><i>d </i>of an opening <b>145</b><i>c </i>of the phased array coil <b>145</b>. An adhesive material may be provided on the mount surface <b>183</b><i>e </i>so that the mount surface <b>183</b><i>e </i>can be temporarily bonded to the surface <b>145</b><i>e </i>of the phased array coil <b>145</b>. According to this embodiment, the inclined surface <b>183</b><i>c </i>of the attachment <b>183</b> is inclined with respect to the attachment surface <b>183</b><i>e </i>by a predetermined angle δ.
0186<figref idref="DRAWINGS">FIG. 42A</figref> is a perspective view and <figref idref="DRAWINGS">FIG. 42B</figref> is a top view of an attachment <b>283</b>. <figref idref="DRAWINGS">FIG. 42A</figref> shows the attachment <b>283</b> includes an upper protruding portion having a cylindrical opening <b>283</b><i>a</i>, a wedge-shaped section having an inclined surface <b>283</b><i>c</i>, and a polygonal protruding portion <b>283</b><i>d</i>. <figref idref="DRAWINGS">FIG. 42C</figref> shows a bottom view of the attachment <b>283</b> showing the polygonal protruding portion <b>283</b><i>d </i>and a mount surface <b>283</b><i>e</i>. The polygonal protruding portion <b>283</b><i>d </i>on the bottom of attachment <b>283</b> is configured so that the attachment <b>283</b> can be positioned and fixed to the phased array coil <b>145</b> (see <figref idref="DRAWINGS">FIG. 19</figref>) by fitting the protruding portion <b>283</b><i>d </i>to the edge <b>145</b><i>d </i>of an opening <b>145</b><i>c </i>of the phased array coil <b>145</b>. To secure the attachment <b>283</b> to the opening <b>145</b><i>c</i>, an adhesive material may be provided on the mount surface <b>283</b><i>e </i>so that the mount surface <b>283</b><i>e </i>can be temporarily bonded to the surface <b>145</b><i>e </i>of the phased array coil <b>145</b>. Additionally, the polygonal protruding portion <b>283</b><i>d </i>is provided with a ridge key <b>283</b><i>g </i>to ensure the adapter is assembled in the correct orientation. Similarly, the upper protruding portion having a cylindrical opening <b>283</b><i>a </i>is configured so that the attachment <b>283</b> can be locked onto the base body <b>2</b> of the apparatus main body <b>1</b>. To that end, the cylindrical opening <b>283</b><i>a </i>is provided with a pressurized protruding pin <b>283</b><i>b</i>. In this manner, the apparatus main body <b>1</b> of the needle placement manipulator is vertically locked with a removable pin/pinhole combination, so that the needle placement manipulator sits atop the inclined surface <b>283</b><i>c </i>and is aligned and rotationally locked with a key/keyway combination. It is understood that this alignment and locking can be implemented in various other ways, including a sliding key, turn lock, or set screw.
0187According to <figref idref="DRAWINGS">FIG. 42A</figref>, the inclined surface <b>283</b><i>c </i>of the attachment <b>283</b> is inclined with respect to the mount surface <b>283</b><i>e </i>by a predetermined angle δ. <figref idref="DRAWINGS">FIG. 42D</figref> shows an example where the inclined surface <b>283</b><i>c </i>is inclined with respect to the mount surface <b>283</b><i>c </i>by a predetermined angle δ of 8 degrees. However, if the predetermined angle δ is not adequate for a desired purpose, the predetermined angle δ can be adjusted, as mentioned above, by adding one or more wedges of, for example, +5 degrees or −5 degrees, on top of the attachment <b>183</b> to get to a desired degree of inclination. In this manner, as illustrated in <figref idref="DRAWINGS">FIG. 44C</figref>, the distance between the inclined surface <b>183</b><i>c </i>and the remote center of motion (RCM) <b>11</b> of the apparatus main body <b>1</b> can be adjusted to a predetermined distance from the patient's surface, such that the remote center of motion (RCM) <b>11</b> of the apparatus main body <b>1</b> can be located at or above the skin <b>15</b>.
0188<figref idref="DRAWINGS">FIG. 43</figref> illustrates an exemplary function of the attachment <b>183</b> during a percutaneous puncture operation to reach a target tissue <b>14</b> using a needle placement manipulator disposed on a patient's skin <b>15</b>. As shown in <figref idref="DRAWINGS">FIG. 3</figref>, by changing the posture of the needle placement manipulator using the attachment <b>183</b> of the present embodiment, the coverage of the needle placement manipulator can be adjusted so that the needle <b>12</b> can be brought to the target tissue <b>14</b>.
0189Specifically, in the case shown in <figref idref="DRAWINGS">FIG. 43</figref>, a doctor first decides the position of the phased array coil <b>145</b> suitable to capture an image of a region of interest, and secures the phased array coil <b>145</b> on the skin <b>15</b> of the patient by using, for example, a tape, a belt, or a band. Subsequently, the attachment <b>183</b> is placed on a surface <b>145</b><i>e </i>of the phased array coil <b>145</b> such that the mount surface <b>183</b><i>e </i>of the attachment <b>183</b> is in contact with the surface <b>145</b><i>e </i>of the phased array coil <b>145</b>. At this time, the protruding portion <b>183</b><i>d </i>protruding from the mount surface <b>183</b><i>e </i>is fitted within the edge <b>145</b><i>d </i>of the coil opening <b>145</b><i>c </i>to adjust the position of the attachment <b>183</b> relative to the phased array coil <b>145</b>. An adhesive material is preferably disposed on the mount surface <b>183</b><i>e </i>to temporarily fix the attachment <b>183</b> to the surface <b>145</b><i>e</i>. Subsequently, the doctor places the apparatus main body <b>1</b> on the inclined surface <b>183</b><i>c </i>of the attachment <b>183</b>. The inclined surface <b>183</b><i>c </i>is inclined at an angle such that the signal processing members <b>145</b><i>a </i>(pre-amplifiers) of the phased array coil <b>145</b> are below the inclined surface <b>183</b><i>c </i>when the attachment <b>183</b> is attached to the phased array coil <b>145</b>. This enables the doctor to place the apparatus main body <b>1</b> above the phased array coil <b>145</b> without the signal processing members <b>145</b><i>a </i>(pre-amplifiers) interfering with the apparatus main body <b>1</b>. The angle of the inclined surface <b>183</b><i>c </i>is in a range of about 5 degrees to about 30 degrees from the perspective of stability of the apparatus main body <b>1</b> during placement. That is, the angle of the inclined surface can be tailored such that the center of gravity (or center of mass) of the apparatus main body <b>1</b> is substantially at equilibrium.
0190The position and posture of the apparatus main body <b>1</b> relative to the attachment <b>183</b> are maintained in a manner in which a ridge key <b>183</b><i>b </i>(protrusion) formed on the inclined surface <b>183</b><i>c </i>is fitted into a groove <b>2</b><i>b </i>formed in the bottom surface of the apparatus main body <b>1</b>, and the protruding portion <b>183</b><i>a </i>formed on the attachment <b>183</b> is fitted into a cylindrical fitting portion <b>2</b><i>a </i>(hole) formed in the base body <b>2</b> of apparatus main body <b>1</b>. The relationship between the groove <b>2</b><i>b </i>and the ridge key <b>183</b><i>b </i>may be interchanged. After the apparatus main body <b>1</b> has been secured, the first and second rotation guides <b>3</b> and <b>4</b> can be rotated such that the insertion axis <b>5</b><i>a </i>of the needle holder <b>5</b> is directed to the target tissue <b>14</b>. Subsequently, a doctor performs a puncture at a depth required to reach the target tissue <b>14</b> by moving the needle <b>12</b> along the insertion axis <b>5</b><i>a</i>. In the event that the first and second rotation guides are rotated, but the insertion axis <b>5</b><i>a </i>of the needle holder <b>5</b> still does not reach the target portion <b>14</b>, the operator (doctor) can use one or more additional wedged adapters until the angle necessary for the needle <b>12</b> to reach the target tissue is achieved.
0191According to the present embodiment, the inclined surface <b>183</b><i>c </i>of the attachment <b>183</b> is inclined at a predetermined angle δ with respect to the mount surface <b>183</b><i>e</i>, and the distance between the inclined surface <b>183</b><i>c </i>and the remote center of motion (RCM) <b>11</b> can be adjusted to a desired distance such that the remote center of motion (RCM) <b>11</b> of the apparatus main body <b>1</b> can be located at or above the skin <b>15</b>. Specifically, in consideration of the deformation the contour shape of the patient's body or due to the rise of the apparatus main body <b>1</b> when the phased array coil <b>145</b> is rigidly attached to the patient's skin, the remote center of motion (RCM) <b>11</b> can be adjusted to be located at about zero (o) to 10 mm above the bottom surface <b>145</b><i>f </i>of the phased array coil <b>145</b>. To that end, the attachment <b>183</b> having an inclined surface <b>183</b><i>c </i>can be arranged by using additional adaptive wedges having a thickness and inclination necessary to achieve the desired height and inclination.
0192<figref idref="DRAWINGS">FIGS. 44A and 44B</figref> show a possible application of attachment <b>183</b> designed as a single piece wedge-shaped adapter. As shown in <figref idref="DRAWINGS">FIGS. 44A and 44B</figref>, an attachment <b>183</b> designed as a statically inclined adapter can be rotated from its original position to adjust the location of the remote center of motion <b>11</b> without changing the device footprint of the device. This rotation can be achieved by rotating the entire assembly, or by having the statically inclined adapter rotate within a base, either manually or electronically. An example of this application is shown in <figref idref="DRAWINGS">FIG. 44</figref> where the apparatus main body <b>1</b> of the needle placement manipulator has been mounted onto an attachment <b>183</b> having a first wedge-shaped adapter <b>1831</b> and a second wedge-shaped adapter <b>1832</b>. In <figref idref="DRAWINGS">FIG. 44</figref>, as compared to <figref idref="DRAWINGS">FIG. 43B</figref>, the use of multiple wedge-shaped adapters causes the remote center of motion <b>11</b> to be placed higher (more distant) with respect to the subject's body.
0193Advantageously, being that the attachment <b>183</b> is a single piece element, it can be manufactured with high precision and at a low cost, for example, by injection molding with a resin material or other materials compatible with the imaging modality to be used. The low-cost manufacture enables the attachment <b>183</b> to be a disposable component. A sterilization process and seal packaging after manufacture enables the attachment <b>183</b> to be maintained in a sterile state until the eventual use, thereby providing an improvement in safety for the patient.
0194Whether the target tissue <b>14</b> is within the coverage of the apparatus main body <b>1</b>, when using the attachment <b>183</b>, is determined using a similar procedure as that described in the previous embodiments. Initially, it is understood that the posture of the attachment <b>183</b> is determined and fixed by the operator (a doctor or imaging technician) in the process of attaching the needle placement manipulator onto the patient. Subsequently, whether the coverage of the apparatus main body <b>1</b> includes the target tissue <b>14</b> is determined through, for example, calculation based on images of fiducial markers <b>16</b> provided on the apparatus main body <b>1</b>. Images of the markers <b>16</b> can be obtained by an X-ray CT scanner or an MRI imaging modality, as applicable. If it is determined that the target tissue <b>14</b> is within the conical coverage of the needle placement manipulator, planning for bringing the needle <b>12</b> to the target tissue <b>14</b> is executed to displace the first and second rotation guides <b>3</b> and <b>4</b> to predetermined angles, thereby directing the needle <b>12</b> in the direction of the target tissue <b>14</b>. On the other hand, if it is determined that the target tissue <b>14</b> is not yet within the desired coverage, the coverage of the needle placement manipulator can be adjusted by placing one or more additional inclined adapters (wedges) above the attachment <b>183</b>.
0195The basis for expanding the coverage of the needle placement manipulator using the attachment <b>183</b> of the present embodiment is similar to that shown and described with reference to <figref idref="DRAWINGS">FIGS. 10A to 10C</figref>. <figref idref="DRAWINGS">FIG. 10A</figref> illustrates the initial coverage of the needle placement manipulator without the use of the attachment <b>183</b>. <figref idref="DRAWINGS">FIG. 10B</figref> illustrates a state in which the posture of the apparatus main body <b>1</b> is inclined (adjusted) by an angle δ using the inclined surface <b>183</b><i>c </i>of attachment <b>83</b>. In this state shown in <figref idref="DRAWINGS">FIG. 10B</figref>, the entire conical coverage <b>108</b> is inclined by the angle δ, as compared to the position shown in <figref idref="DRAWINGS">FIG. 10A</figref>. If the attachment <b>183</b> is extracted from the opening <b>145</b><i>c </i>of the phased coil array <b>145</b> and rotated, the conical coverage <b>108</b> can be adjusted by an angle δ across the four sides of the opening <b>145</b><i>c</i>. Accordingly, the coverage of the needle placement manipulator is increased to a conical region <b>109</b> enclosed by the dashed line with an apical angle of 4θ+2δ and with the remote center of motion <b>11</b> as a vertex thereof, as illustrated in <figref idref="DRAWINGS">FIG. 10C</figref>.
0196In this embodiment, as shown in <figref idref="DRAWINGS">FIGS. 41A, 41B and 41C</figref>, a ridge key <b>183</b><i>b </i>on the inclined surface <b>183</b><i>c </i>of the single element attachment <b>183</b> aligns with a groove <b>2</b><i>b </i>(keyway) of the base body <b>2</b> to ensure the adapter is assembled in the correct orientation. In the case of using one or more additional wedge-shaped adapters, additional pairs of ridge key and groove combinations are to be used. In this manner, the needle placement manipulator sits atop the inclined surface of the wedge-shaped adapter using another ridge key/keyway pair for alignment. The inclined adapter can be designed at a fixed angle, for example of 8 degrees, to ensure the manipulator will avoid an amplifier circuit (signal processing member <b>145</b><i>a</i>) which sits adjacent to an edge <b>145</b><i>d </i>of an opening <b>145</b><i>c </i>on the phased coil array <b>145</b>, as shown in <figref idref="DRAWINGS">FIG. 43</figref>.
0197The apparatus main body <b>1</b> and the attachments <b>183</b> suitable to various RF coils can be prepared without a major design change of the apparatus main body, so that the remote center of motion (RCM) can be located at the intended position, and the position and posture of the apparatus main body can be determined without interference with the RF coils.
0198According to the present embodiment, the needle positioning apparatus including the attachment can be placed on a patient after the RF coil is placed on the patient. And even if it is found out that the target tissue is not within the coverage of a needle placement manipulator after the needle placement manipulator is placed, the coverage can be corrected so that the target issue falls within the coverage by adjustment using the attachment <b>183</b>. For this reason, it is possible to remove something that can interfere with the RF coil from the skin during a process of searching the position at which the RF coil is to be placed in a workflow of a puncture surgery.
0199According to the embodiment, an example of using the attachment <b>183</b> with a phased-array coil as the RF coil is described. In other cases, however, the attachment <b>183</b> can also be used with a single loop coil <b>135</b> (shown in <figref idref="DRAWINGS">FIG. 16C</figref>), which is another kind of surface RF coil that can be placed on a patient's skin <b>15</b>.
0200As contemplated in this embodiment (see <figref idref="DRAWINGS">FIGS. 41A and 42A</figref>), the attachment <b>183</b> or attachment <b>283</b> can be designed as a single element wedge-shaped adapter having an inclined surface with a predetermined angle of inclination. This design can be extremely useful and advantageous due to the lack of moving parts, and more importantly it can be made disposable. However, due to the flexibility of the phased array coil, the single element wedge-shaped adapter may not be applicable in all situations. Therefore, ensure that the attachment <b>183</b> is properly combined with the RF coil, a base or a setting portion on which the RF coil is set may be used.
0201<figref idref="DRAWINGS">FIG. 45</figref> illustrates an example of attachment <b>183</b> mounted onto a subject's body with a phased array coil <b>145</b> therebetween. As shown in <figref idref="DRAWINGS">FIG. 45</figref>, the phased array coil <b>145</b> wraps around the skin <b>15</b> of the subject's body. When a region of interest, e.g., target tissue <b>14</b>, is located below a surface where the attachment <b>183</b> does not sit flush in its intended position, a base <b>190</b> can be designed for mounting the coil <b>145</b> onto the subject's body, and a mounting surface of the base (the surface in direct contact with the subject's body) can be also designed according to the contour shape of the subject's body. <figref idref="DRAWINGS">FIG. 46</figref> shows a side view arrangement of the base <b>190</b> and the attachment <b>183</b>. As shown in <figref idref="DRAWINGS">FIG. 46</figref>, the base <b>190</b> includes an upper protruding portion <b>1902</b>, a setting potion <b>1903</b> on which the RF-coil is set, and a curved mounting surface <b>1904</b> configured to fit the contour shape of a patient's body.
0202In this embodiment, the base <b>190</b> configured to be placed on the patient's torso may be designed containing registration fiducials <b>16</b>. The phased array RF-coil <b>145</b> is then placed over the base <b>190</b> by aligning one of the openings <b>145</b><i>c </i>with the upward protruding portion <b>1902</b> of the base <b>190</b>. To facilitate a better fit of the attachment <b>183</b> onto the base <b>190</b>, the upward protruding portion can be designed with an inclined surface <b>191</b>. The attachment <b>183</b> having one or more wedge-shaped adapters (<b>1831</b>, <b>1832</b>) is then placed atop this upward protrusion <b>1902</b>, securing the RF-coil <b>145</b> in place between the base <b>190</b> and the wedge-shaped adapter. A key on the attachment can be used to align with a keyway along the protrusion <b>1902</b> to ensure the adapter is assembled in the correct orientation with respect to the subject's body. The apparatus main body <b>1</b> of manipulator then sits atop the inclined surface <b>183</b><i>c </i>of attachment <b>183</b> using another key/keyway for alignment. This inclined adapter is at a fixed angle to ensure the manipulator will avoid an amplifier enclosure (processing unit <b>145</b><i>a</i>) which sits adjacent to the opening on the coil.
0203In one experiment conducted by the inventors herein, a wedge-shaped adapter having an angle of 8 degrees was selected for a number of reasons. First, it is the minimum angle necessary to avoid collision with the amplifier enclosure. Second, it is necessary to minimize the loss of accessible area of the manipulator. Specifically, since the manipulator is angled, the base begins to encroach upon the conical range of accessible area of the manipulator, the angle of the wedged adapter is necessary to minimize the loss of accessible area. Lastly, it is preferable that the RCM of the manipulator be as close to the original location as possible. Due to the fact that the adapter has to sit atop the fixed protrusion of the base, the angulation cannot rotate about the RCM of the manipulator. Therefore, RCM is raised away from the non-angled position as the angulation increases. This is undesired as it decreases the depth that the manipulator can reach and increases the size of the potential needle insertion area upon the skin surface.
0204For example, as shown in <figref idref="DRAWINGS">FIG. 19</figref>, the amplifier boxes (signal processing units <b>145</b><i>a</i>) lay medially from the openings <b>145</b><i>c</i>, therefore there are only two different ways the assembly can sit within the phased array coil <b>145</b>. Knowing that the phased array coil <b>145</b> typically wraps around the patient torso along the transverse direction of the patient, the base <b>190</b> can be designed with a curved bottom surface (mounting surface <b>1904</b>) to align with the curved shape of the torso for a better fit. The radius of this curve can vary so different bases can be used for different body shapes and sizes.
0205<figref idref="DRAWINGS">FIG. 46B</figref> illustrates a base <b>190</b> having a curved mounting surface <b>1904</b> adapted to fit the contour shape of a patient. In <figref idref="DRAWINGS">FIG. 46B</figref>, the base <b>190</b> is designed with a protrusion <b>192</b> where angulation can integrated into the protrusion, and an inclined surface <b>1901</b> replaces the attachment <b>183</b> thereby removing the need of an additional wedge-shaped adapter to sit atop the base. That is, the attachment <b>183</b> having an inclined surface <b>183</b><i>c </i>can be combined with the base <b>190</b> into a single piece, as shown in <figref idref="DRAWINGS">FIG. 46B</figref>. This can be done by angling the upward protrusion <b>1902</b> by the desired angle (e.g., 8 degrees as mentioned above). The needle placement manipulator then sits atop this base with an angled protrusion, and is aligned and rotationally locked with a key/keyway combination, and vertically locked with a removable pin/pinhole combination, as explained above.
0206One benefit of this design is the removal of the base encroaching upon the reachable area of the manipulator. Since the protrusion will run perpendicular to the bottom surface of the manipulator, the reachable area will be untouched by the base as long as the height of the protrusion is within the desired range. An additional benefit of this design is the fact that the angle of the manipulator can be adjusted without changing the position of the remote center of motion. Since this angulation is integrated into the base, the rotation can occur about the remote center of motion, and the height of the remote center of motion can be controlled by controlling the height of the protrusion. In this embodiment, a base containing registration fiducials can be placed on the patient's torso.
Ninth Embodiment
0207<figref idref="DRAWINGS">FIGS. 47A, 47B, and 47C</figref> show an embodiment of an attachment <b>183</b> mounted on one or more linear guides <b>200</b>, <b>201</b>, and <b>202</b>. As shown in <figref idref="DRAWINGS">FIG. 47A</figref>, the attachment <b>183</b> having an inclined surface of a predetermined angle can be combined with a fixed distance translation adapter (a linear guide), which can be used to move the apparatus main body <b>1</b> of needle placement manipulator a specific distance away from its original position. For example, after placing the needle placement manipulator on the patient and performing medical imaging, the clinician may determine that the device needs to be shifted a predetermined distance (e.g., 20 mm) to be able to reach the target tissue <b>14</b>. Therefore, a fixed distance translation adapter can be placed between the apparatus main body <b>1</b> and the attachment to shift the device by the specific amount (e.g. a distance of 20 mm). If a different displacement is needed, additional translation adapters may be stacked to create a specific distance. For example, a 5 mm or −5 mm displacement adapter can be used in addition to the 20 mm adapter to create a 25 mm or 15 mm displacement. In this manner, a fixed translation adapter can be used in conjunction with a fixed angled adapter to move the RCM to another location along the inclined plane of the inclined surface. For example, a fixed translation adapter designed specifically for a 30 degree angled adapter can be used to move the device in such a manner than the zero/initial trajectory lines up with the position of the RCM before the angled adapter was placed. <figref idref="DRAWINGS">FIG. 47B</figref> shows a perspective view and <figref idref="DRAWINGS">FIG. 47C</figref> shows a cross sectional view of an apparatus main body <b>1</b> mounted onto a plurality of linear guides <b>200</b>, <b>201</b> and <b>202</b> which can be used to linearly move the needle placement manipulator along the inclined surface <b>183</b><i>c </i>of the attachment <b>183</b> in one or more directions. For example, as shown in <figref idref="DRAWINGS">FIG. 47B</figref>, a first linear guide <b>200</b> can move the apparatus maim body <b>1</b> a fixed distance in the x-direction, and a second liner guide <b>201</b> can move the apparatus maim body <b>1</b> a fixed distance in the y-direction, while a third linear guide <b>202</b> is fixed onto the inclined surface <b>183</b><i>c </i>of the attachment <b>183</b>. Accordingly, with the use of one or more linear guides combined with the inclined surface of the wedge-shaped adapter, as described in the present embodiment, it is not only possible to adjust the conical region of coverage, but it is also possible to move the conical region of coverage so that a target tissue outside of the conical region of coverage can be reached by the needle of the needle placement manipulator.
0208As a result, even if it is found that the target tissue is outside of the coverage of a needle placement manipulator after the needle placement manipulator is placed on a patient's body, the coverage can be corrected by adjustment using the attachment and one or more linear guides so that the target issue falls within the coverage.
0209As it will be appreciated by those skilled in the art, if the inclined surface <b>183</b><i>c </i>is visible in the medical images acquired by the imaging modality, the posture of the needle guide device can be known in advance, before the needle placement manipulator is even mounted on the patient. Note that without this type of inclined surface, the posture of the needle guide device is unknown when it is mounted because the patient skin has curved shape and can deform. Therefore, the use of an attachment having an inclined surface can reflect that posture information to the plan before the device is actually mounted.
0210In addition, when the base <b>190</b> is designed according to the contour shape of the subject's body, the base <b>190</b> can be made by 3D printing or any other rapid prototyping technique based on the actual individual patient contour shape data from the medial image. Accordingly, with those pre-designed patient contour, it can become much easier reflect/design the posture and even the position of the needle guide device before even planning the trajectory of the percutaneous puncture. Therefore, the use of an attachment having a predefined inclined surface in particular when fiducial markers are included in the base of the attachment is considered a unique advantage of the present disclosure.
0211While the present invention has been described with reference to exemplary embodiments, it is to be understood that the invention is not limited to the disclosed exemplary embodiments. The scope of the following claims is to be accorded the broadest interpretation so as to encompass all modifications and equivalent structures and functions. To that end, it should be understood that the singular forms “a”, “an”, and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It should be further understood that the terms “includes” and/or “including”, “comprises” and/or “comprising” when used in the present specification and claims, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof not explicitly stated. The terms “consists of” and/or “consisting of” when used in the present specification and claims, specify the presence of a closed group of stated features, integers, steps, operations, elements, and/or components, and excludes the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof not explicitly stated.
0212The terms first, second, third, etc. may be used herein to describe various elements, components, regions, parts and/or sections. It should be understood that these elements, components, regions, parts and/or sections are not limited by these terms of designation. These terms of designation have been used only to distinguish one element, component, region, part, or section from another region, part, or section. Thus, a first element, component, region, part, or section discussed below could be termed a second element, component, region, part, or section merely for purposes of distinction but without departing from structural or functional meaning.
0213It should be further understood that if an element or part is referred herein as being “on”, “against”, “connected to”, or “coupled to” another element or part, then it can be directly on, against, connected or coupled to the other element or part, or intervening elements or parts may be present. In contrast, if an element is referred to as being “directly on”, “directly connected to”, or “directly coupled to” another element or part, then there are no intervening elements or parts present. When used, term “and/or”, includes any and all combinations of one or more of the associated listed items, if so provided.
0214Lastly, spatially relative terms, such as “under” “beneath”, “below”, “lower”, “above”, “upper”, “proximal”, “distal”, and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the various figures. It should be understood, however, that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, a relative spatial term such as “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein are to be interpreted accordingly. Similarly, the relative spatial terms “proximal” and “distal” may also be interchangeable, where applicable.
LIST OF EXEMPLARY REFERENCES
0215The following non-patent literature (NPL) and patent publications, which are considered “nonessential material”, are hereby incorporated by reference herein in their entirety: <ul id="ul0001" list-style="none"><li id="ul0001-0001" num="0216">1. Liu S, Xia Z, Liu J, Xu J, Ren H, Lu T, et al., “Automatic Multiple-Needle Surgical Planning of Robotic-Assisted Microwave Coagulation in Large Liver Tumor Therapy”, the public library of science (PLoS) ONE11(3): e0149482. Published: Mar. 16, 2016, https://doi.org/10.1371/journal.pone.0149482;</li><li id="ul0001-0002" num="0217">2. Ken Masamune, Etsuko Kobayashi, Yoshitaka Masutani, Makoto Suzuki, Takeyoshi Dohi, Hiroshi Iseki & Kintomo Takakura, “Development of an MRI-Compatible Needle Insertion Manipulator for Stereotactic Neurosurgery”, Journal of Image Guided Surgery Vol. 1, Iss. 4, 1995;</li><li id="ul0001-0003" num="0218">3. Patent publications include: US20040260312, US20060229641, US20080200798, US20100082040, US20110190787, US20120022368, US2013028022, US 20140121675, US20140128881, US20140128883, and US20140275978</li></ul>
Contents6
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Numbers
- Publication
- 10695087
- Publication, DOCDB
- 10695087
- Publication, EPODOC
- US10695087
- Application
- 15787536
- Application, DOCDB
- 201715787536
- Application, EPODOC
- US201715787536
Titles
- English
- Placement manipulator and attachment for positioning a puncture instrument
Patent term adjustment
- A delay
- +370 daysthe office missed an examination deadline
- Net adjustment
- 370 days
Classification
- CPC, 7
- A61B17/3403
- A61B90/11
- A61B2090/374
- A61B10/0233
- A61B2017/3407
- G01R33/286
- G01R33/287
- IPC, 5
- A61B17 34
- G01R33 28
- A61B90 11
- A61B10 02
- A61B90 00